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MicroPort Orthopedics Inc.
MicroPort Orthopedics Inc.: 33 FDA recall reports
Every medical device recall the FDA has published for MicroPort Orthopedics Inc.. The fault, and how the agency graded it.
33Reports
14Class I
6Ongoing
2026-01-28Most recent
14 Class I on this pageClass I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Sof
Z-1133-2026 · Class II · reported 2026-01-28 · Ongoing
- Why it was recalled
- Due to products not having FDA Premarket authorization to be distributed within the United States.
- Product
- Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE
- Where it went
- The product was sent to distributors in multiple US states, including Texas, California, Wisconsin, Kansas, Illinois, Michigan, Tennessee, Maryland, Washington, Georgia, Colorado, Missouri, and Florida. The product was also sent to the following countries: Belgium, Germany, France, Italy, United Kingdom, Japan, and China.
- How much
- 91
EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPO
Z-0699-2025 · Class II · reported 2024-12-25 · Ongoing
- Why it was recalled
- Femoral implant porous size 5 right primary and femoral implant non-porous size 6 left primary have correct markings on devices, but may have incorrect packaging.
- Product
- EVOLUTION MP FEMORAL COMPONENT CS/CR POROUS SIZE 5 RIGHT PRIMARY, REF: EFSRP5PR; EVOLUTION MP FEMORAL COMPONENT CS/CR NON-POROUS SIZE 6 LEFT PRIMARY, REF: EFSRN6PL Knee prosthesis component
- Where it went
- OUS: CN, GR, ES, ZA, FR, JP, IT
- How much
- 32
EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemente
Z-2244-2024 · Class II · reported 2024-07-10 · Ongoing
- Why it was recalled
- One confirmed incident has been received that EFSRN4PR, lot number MP1982170, Size 4 Evolution MP Non-Porous Femoral Right was opened during surgery and contained part number EFSRN3PL, lot number MP1982097, Size 3 Evolution MP Non-Porous Femoral Left in the packaging.
- Product
- EVOLUTION¿ MP Femoral CS/CR Non-Porous Non-porous MicroPort total knee replacement implants are for cemented use only.
- Where it went
- International distribution in the country of China. There is no field inventory in the United States for either lot.
- How much
- 40 units
EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
Z-0276-2023 · Class II · reported 2023-02-22 · Ongoing
- Why it was recalled
- One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.
- Product
- EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
- Where it went
- International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.
- How much
- 22 units
EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
Z-0275-2023 · Class II · reported 2023-02-22 · Ongoing
- Why it was recalled
- One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.
- Product
- EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base
- Where it went
- International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.
- How much
- 24 units
PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
Z-1225-2022 · Class II · reported 2022-06-08 · Terminated
- Why it was recalled
- One manufacturing lot is missing the plasma-spray coating in the proximal region of the stem body.
- Product
- PROFEMUR PLASMA Z CLASSIC STEM SIZE 7 STANDARD SHORT NECK
- Where it went
- Worldwide distribution - US Nationwide distribution in the states of FL, IN, MO, CA and the country of Canada.
- How much
- 8 units
Class I
PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA
Z-2941-2020 · Class I · reported 2020-09-30 · Terminated
- Why it was recalled
- MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680 Long and X-Long PROFEMUR Titanium modular neck fractures among 123,840 global sales representing is a cumulative rate of modular neck device fracture of 0.55% from 2002 to 2019. Within the United States there were 349 Long and X-Long PROFEMUR¿ Titanium modular neck fractures among 15,786 United States sales representing a cumulative rate of modular neck device fracture with a fracture rate in the United States of 2.21% from 2002 to 2019. There is an average time of 5.4 years to device fracture after implantation.
- Product
- PROFEMUR Neck Long Titanium, Catalog Numbers: PHA01204, PHA01214, PHA01224, PHA01234, PHA01244, PHA01254, PHA01264. Hip prosthesis component.
- Where it went
- worldwide, except China and Japan
- How much
- 123,284 units
Class I
PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component
Z-2942-2020 · Class I · reported 2020-09-30 · Terminated
- Why it was recalled
- MicroPort Orthopedics Inc. states that there have been reports of fractures of the long and extra-long Titanium modular femoral neck component after implantation. Worldwide there were 680 Long and X-Long PROFEMUR Titanium modular neck fractures among 123,840 global sales representing is a cumulative rate of modular neck device fracture of 0.55% from 2002 to 2019. Within the United States there were 349 Long and X-Long PROFEMUR Titanium modular neck fractures among 15,786 United States sales representing a cumulative rate of modular neck device fracture with a fracture rate in the United States of 2.21% from 2002 to 2019. There is an average time of 5.4 years to device fracture after implantation.
- Product
- PROFEMUR Neck Extra Long Titanium, Catalog Numbers: PHA01206, PHA01236, PHA01256. Hip prosthesis component
- Where it went
- worldwide, except China and Japan
- How much
- 556 units
PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Des
Z-2948-2020 · Class II · reported 2020-09-16 · Ongoing
- Why it was recalled
- MicroPort Orthopedics Inc. is voluntarily recalling any existing inventory of PROFEMUR¿ Titanium and Cobalt Chrome modular necks with previous package insert versions to replace the PROFEMUR¿ Hip System Package Insert with the most recent revision (150803-8).
- Product
- PROFEMUR Titanium and Cobalt Chrome modular necks, Item Numbers and descriptions: Item Number Description Description 2 PHAC1202 PROFEMUR NECK NEUTRAL SHORT COBALT CHROME PHAC1204 PROFEMUR NECK NEUTRAL LONG COBALT CHROME PHAC1212 PROFEMUR NECK A/R VAR/VAL 2 SHORT COBALT CHROME PHAC1214 PROFEMUR NECK A/R VAR/VAL 2 LONG COBALT CHROME PHAC1222 PROFEMUR NECK A/R VAR/VAL 1 SHORT COBALT CHROME PHAC1224 PROFEMUR NECK A/R VAR/VAL 1 LONG COBALT CHROME PHAC1232 PROFEMUR NECK A/R 8DG SHORT COBALT CHROME PHAC1234 PROFEMUR NECK A/R 8DG LONG COBALT CHROME PHAC1242 PROFEMUR NECK A/R 15DG SHORT COBALT CHROME PHAC1244 PROFEMUR NECK A/R 15DG LONG COBALT CHROME PHAC1252 PROFEMUR NECK VAR/VAL 8DG SHORT COBALT CHROME PHA01202 PROFEMUR NECK NEUTRALSHORT SHORT PHA01204 PROFEMUR NECK NEUTRAL LONG PHA01206 PROFEMUR NECK NEUTRAL X LONG PHA01212 PROFEMUR NECK A/R VAR/VAL 2 SHORT PHA01214 PROFEMUR NECK A/R VAR/VAL 2 LONG PHA01222 PROFEMUR NECK A/R VAR/VAL 1 SHORT PHA01224 PROFEMUR NECK A/R VAR/VAL 1 LONG PHA01232 PROFEMUR NECK 8DG A/R SHORT PHA01234 PROFEMUR NECK 8DG A/R LONG PHA01236 PROFEMUR NECK 8DG A/R X LONG PHA01242 PROFEMUR NECK 15DG A/R SHORT PHA01244 PROFEMUR NECK 15DG...
- Where it went
- Worldwide Distribution: US (nationwide) to states of: AL, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, MA, MD, MI, MO, MT, NC, NH, NJ, NV, OH, PA, TN, TX, UT, VA, WA, WI including PR; and countries of: Brazil, Canada, China, Costa Rica, France, Germany, Japan, The Netherlands and United Kingdom.
- How much
- 12,348 units
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total
Z-0043-2018 · Class II · reported 2017-11-01 · Terminated
- Why it was recalled
- The item is being recalled due to an inadequate pouch seal. This defect has the potential to lead to a loss of sterile pouch integrity, which could impact the products sterility assurance and may lead to serious adverse events such as infections, both localized and systemic.
- Product
- MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed
- Where it went
- Worldwide Distribution - US Nationwide in the states of TX, AL, AZ CO, KS ,ME MO, WB, LA, CA, MD, including PR and the country of CANADA
- How much
- 48 units
PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instrument
Z-0943-2017 · Class II · reported 2017-01-11 · Terminated
- Why it was recalled
- The recall is being initiated because all broach handles in the affected lot had the same non-conformity with the connection feature. The broach handles may have machining issues that do not allow the handle to properly mate with an associated broach.
- Product
- PROFEMUR(R) R RASP HANDLE, REF PPW38078, 1 EACH, NON-STERILE, MicroPort Orthopedics, Arlington, TN Instruments support the implantation of implants. Broach handles mate to the broach to allow for preparation of the femoral canal for the stem component to be implanted. This
- Where it went
- Worldwide Distribution to Spain, China, and Italy
- How much
- 20 units
Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF DLCOGF42, REF DLCOG
Z-0684-2017 · Class III · reported 2016-12-07 · Terminated
- Why it was recalled
- Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.
- Product
- Dynasty Liners: REF DLCOGA28, REF DLCOGB32, REF DLCOGC36, REF DLCOGD38, REF DLCOGE40, REF DLCOGF42, REF DLCOGG44, REF DLCOGH48, REF DLCOGJ52, REF DLCOGK56, For use with the conserve metal head
- Where it went
- Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.
- How much
- 6,250 units
Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26000021, 26000022, 26000023, 26000
Z-0689-2017 · Class III · reported 2016-12-07 · Terminated
- Why it was recalled
- Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.
- Product
- Cobalt Chromium Heads Transcend: 26000017, 26000018, 26000019, 26000020, 26000021, 26000022, 26000023, 26000024, 26000025, 26000026, 26000027, 26000028 Conserve: 38013800, 38013804, 38013835, 38014000, 38014004, 38014035, 38014200, 38014204, 38014235, 38014400, 38014404, 38014435, 38014600, 38014604, 38014635, 38014800, 38014804, 38014835, 38015000, 38015004, 38015035, 38015200, 38015204, 38015235, 38015400, 38015404, 38015435, 38015600, 38015604, 38015635, 38AC3600, 38AC3800, 38AC4000, 38AC4200, 38AC4400, 38AC4600, 38AC4800, 38AC5000, 38AC5200, 38AC5400, 38AC5600, 38AM3600, 38AM3604, 38AM3635, 38AM3800, 38AM3804, 38AM3835, 38AM4000, 38AM4004, 38AM4035, 38AM4200, 38AM4204, 38AM4235, 38AM4400, 38AM4404, 38AM4435, 38AM4600, 38AM4604, 38AM4635, 38AM4800, 38AM4804, 38AM4835, 38AM5000, 38AM5004, 38AM5035, 38AM5200, 38AM5204, 38AM5235, 38AM5400, 38AM5404, 38AM5435, 38AM5600, 38AM5604, 38AM5635, PL38HM4400, PL38HM4404, PL38HM4435, PL38HM4600, PL38HM4604, PL38HM4635, PL38HM4800, PL38HM4804, PL38HM4835, PL38HM5000, PL38HM5004, PL38HM5035, PL38HM5200, PL38HM5204, PL38HM5235
- Where it went
- Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.
- How much
- 108,362 units
Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA047
Z-0685-2017 · Class III · reported 2016-12-07 · Terminated
- Why it was recalled
- Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.
- Product
- Procotyl (Rim- Lock) Liners: REF PHA04702, REF PHA04704, REF PHA04706, REF PHA04708, REF PHA04710, REF PHA04712, REF PHA04714 For use with the conserve metal head
- Where it went
- Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.
- How much
- 500 units
Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF
Z-0688-2017 · Class III · reported 2016-12-07 · Terminated
- Why it was recalled
- Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.
- Product
- Conserve Cups: REF 38BF3642, REF 38BF3642SP, REF 38BF3844, REF 38BF3844SP, REF 38BF4046, REF 38BF4046SP, REF 38BF4248, REF 38BF4248SP, REF 38BF4450, REF 38BF4450SP, REF 38BF4652, REF 38BF4652SP, REF 38BF4854, REF 38BF5056, REF 38BF5258, REF 38BF5258SP, REF 38BF5460, REF 38BF5460SP, REF 38BF5662, REF 38BF5662SP, REF 38BF5864, REF 38BF5864SP, REF 38BF6066, REF 38BF6066SP, REF 38QH3644, REF 38QH3846, REF 38QH4048, REF 38QH4250, REF 38QH4452, REF 38QH4654, REF 38QH4856, REF 38QH5058, REF 38QH5260, REF 38QH5462, REF 38QH5664, REF 38QH5666, REF 38SC3650, REF 38SC3852, REF 38SC4054, REF 38SC4256, REF 38SC4458, REF 38SC4660, REF 38SC4862, REF 38SC5064, REF 38SC5266, REF 38SC5468, REF 38SC5670, REF 38SC5672 For use with the conserve metal head
- Where it went
- Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.
- How much
- 68,221 units
Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156, REF 3802
Z-0687-2017 · Class III · reported 2016-12-07 · Terminated
- Why it was recalled
- Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.
- Product
- Conserve Shells: REF 38021146, REF 38021148, REF 38021150, REF 38021152, REF 38021154, REF 38021156, REF 38021158, REF 38021160, REF 38021162, REF 38021164, REF 38023642, REF 38023646, REF 38023844, REF 38023848, REF 38024046, REF 38024050, REF 38024248, REF 38024252, REF 38024450, REF 38024454, REF 38024652, REF 38024656, REF 38024854, REF 38024858, REF 38025056, REF 38025060, REF 38025258, REF 38025262, REF 38025460, REF 38025464, REF 38025662, REF 38025664, REF 38025666, REF 38025668, REF 38123844, REF 38124046, REF 38124248, REF 38124450, REF 38125056, REF 38125662, REF 38HA3642, REF 38HA3844, REF 38HA4046, REF 38HA4248, REF 38HA4450, REF 38HA4652, REF 38HA4854, REF 38HA5056, REF 38HA5258, REF 38HA5460, REF 38HA5662, REF 38HA5664, REF 38HA5864, REF 38HA6066, REF 38SP3642, REF 38SP3844, REF 38SP4046, REF 38SP4248, REF 38SP4450, REF 38SP4652, REF 38SP4854, REF 38SP5056, REF 38SP5258, REF 38SP5460, REF 38SP5662, REF 38SP5664 For use with the conserve metal head
- Where it went
- Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.
- How much
- 68,199 units
Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 3669485
Z-0686-2017 · Class III · reported 2016-12-07 · Terminated
- Why it was recalled
- Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.
- Product
- Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252, REF 36694454, REF 36694656, REF 36694858, REF 36695060, REF 36695262, REF 36695464 For use with the conserve metal head
- Where it went
- Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.
- How much
- 22 units
Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403
Z-0683-2017 · Class III · reported 2016-12-07 · Terminated
- Why it was recalled
- Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and it was found that there was a specific hazard/harm for suspected tissue reaction to metal debris over one percent for modular head CONSERVE(R) systems and DYNASTY(R) metal acetabular liner systems.
- Product
- Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF 70302858, REF 70303258, REF 70402864, REF 70403264, REF 70403664 For use with the conserve metal head
- Where it went
- Worldwide Distribution - US (nationwide) Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Columbia, Cyprus, Czech Republic, Denmark, Finland, France, Georgia, Germany, Greece, Iran, Italy, Jamaica, Japan, Lithuania, Malaysia, Philippines, Poland, Portugal, Russia, Slovenia, South Africa, South Korea, Spain, Switzerland, Taiwan, Netherlands, Turkey, Arab Emirates, United Kingdom, and Vietnam.
- How much
- 5,009 units
Class I
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA41, SIZE 4+; SURFACE POROUS, HA C
Z-2700-2016 · Class I · reported 2016-09-14 · Terminated
- Why it was recalled
- ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Product
- ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA41, SIZE 4+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
- Where it went
- Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
- How much
- 77 units
Class I
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA10, SIZE 1 STD; SURFACE POROUS, H
Z-2693-2016 · Class I · reported 2016-09-14 · Terminated
- Why it was recalled
- ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Product
- ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA10, SIZE 1 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
- Where it went
- Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
- How much
- 34 units
Class I
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA40, SIZE 4 STD; SURFACE POROUS, H
Z-2699-2016 · Class I · reported 2016-09-14 · Terminated
- Why it was recalled
- ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Product
- ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA40, SIZE 4 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 4 FEMUR & SIZE 4 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
- Where it went
- Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
- How much
- 134 units
Class I
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA11, SIZE 1+; SURFACE POROUS, HA C
Z-2694-2016 · Class I · reported 2016-09-14 · Terminated
- Why it was recalled
- ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Product
- ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA11, SIZE 1+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
- Where it went
- Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
- How much
- 36 units
Class I
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA30, SIZE 3 STD; SURFACE POROUS, H
Z-2697-2016 · Class I · reported 2016-09-14 · Terminated
- Why it was recalled
- ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Product
- ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA30, SIZE 3 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
- Where it went
- Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
- How much
- 169 units
Class I
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA20, SIZE 2 STD; SURFACE POROUS, H
Z-2695-2016 · Class I · reported 2016-09-14 · Terminated
- Why it was recalled
- ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Product
- ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA20, SIZE 2 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
- Where it went
- Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
- How much
- 110 units
Class I
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA50, SIZE 5 STD; SURFACE POROUS, H
Z-2701-2016 · Class I · reported 2016-09-14 · Terminated
- Why it was recalled
- ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Product
- ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA50, SIZE 5 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
- Where it went
- Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
- How much
- 60 units
Class I
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA31, SIZE 3+; SURFACE POROUS, HA C
Z-2698-2016 · Class I · reported 2016-09-14 · Terminated
- Why it was recalled
- ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Product
- ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA31, SIZE 3+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 3 FEMUR & SIZE 3 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY,MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
- Where it went
- Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
- How much
- 86 units
Class I
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA21, SIZE 2+; SURFACE POROUS, HA C
Z-2696-2016 · Class I · reported 2016-09-14 · Terminated
- Why it was recalled
- ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Product
- ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA21, SIZE 2+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 2 FEMUR & SIZE 2 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
- Where it went
- Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
- How much
- 98 units
Class I
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6 STD; SURFACE POROUS, H
Z-2703-2016 · Class I · reported 2016-09-14 · Terminated
- Why it was recalled
- ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Product
- ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 6 FEMUR & SIZE 6 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
- Where it went
- Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
- How much
- 38 units
Class I
ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA51, SIZE 5+; SURFACE POROUS, HA C
Z-2702-2016 · Class I · reported 2016-09-14 · Terminated
- Why it was recalled
- ADVANCE(R) HA Coated tibial bases are being recalled due to a higher than expected revision rate as a result of component loosening.
- Product
- ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA51, SIZE 5+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 5 FEMUR & SIZE 5 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
- Where it went
- Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom
- How much
- 47 units
PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthropla
Z-2588-2016 · Class II · reported 2016-08-24 · Terminated
- Why it was recalled
- Profemur(R) neck, Item Number PHA01222 (Short AR VV2 Ti Neck) was labeled as Item Number PHA01212 (Short AR VV1 Ti Neck).
- Product
- PROFEMUR(R) MODULAR NECK, HIP FEMORAL NECK MicroPort total hip systems intended for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients.
- Where it went
- Belgium, Italy, Spain, and Poland
- How much
- 14 units
Showing the 30 most recent of 33. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
← All device recalls