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DePuy Orthopaedics, Inc.
DePuy Orthopaedics, Inc.: 155 FDA recall reports
Every medical device recall the FDA has published for DePuy Orthopaedics, Inc.. The fault, and how the agency graded it.
155Reports
5Class I
8Ongoing
2024-04-10Most recent
5 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.
ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee
Z-1456-2024 · Class II · reported 2024-04-10 · Ongoing
- Why it was recalled
- Product incorrectly labelled.
- Product
- ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
- Where it went
- Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the country of Canada.
- How much
- 5 units
Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
Z-1263-2023 · Class II · reported 2023-03-29 · Ongoing
- Why it was recalled
- The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
- Product
- Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
- How much
- 7 units
Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
Z-1266-2023 · Class II · reported 2023-03-29 · Ongoing
- Why it was recalled
- The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
- Product
- Attune Revision Limb Preservation System (LPS) Tibial Insert SM 12MM, Part Number 151760312
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
- How much
- 7 units
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
Z-1264-2023 · Class II · reported 2023-03-29 · Ongoing
- Why it was recalled
- The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
- Product
- Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 12MM, Part Number 151760212
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
- How much
- 7 units
Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
Z-1265-2023 · Class II · reported 2023-03-29 · Ongoing
- Why it was recalled
- The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
- Product
- Attune Revision Limb Preservation System (LPS) Tibial Insert XSM 26MM, Part Number 151760226
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
- How much
- 7 units
Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
Z-1267-2023 · Class II · reported 2023-03-29 · Ongoing
- Why it was recalled
- The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to the implant material properties.
- Product
- Attune Posterior (PS) Fixed Bearing (FB) Tibial Insert SZ5 7MM, Part Number 151640507
- Where it went
- Worldwide distribution - US Nationwide and the countries of Canada, Poland, Germany, India, Australia, & New Zealand
- How much
- 12 units
ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation
Z-1419-2022 · Class II · reported 2022-07-27 · Ongoing
- Why it was recalled
- Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical delay, debris in surgical field, Osteolysis, Poor Joint Mechanics, Soft Tissue Irritation, Pain
- Product
- ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant Part Number: 254400525
- Where it went
- Nationwide Foreign: Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Kuwait, Lithuania, Mauritius, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Saudi Arabia, Serbia, Singapore, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, United Arab Emirates, United Kingdom, Vietnam
- How much
- 872 units
MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Produ
Z-1375-2022 · Class II · reported 2022-07-20 · Ongoing
- Why it was recalled
- The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification that the +5mm offset should be taken into consideration when using a Cathcart head in a construct for hemi-hip arthroplasty procedures.
- Product
- MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000, 136343000, 136344000, 136345000, 136346000, 136347000, 136348000, 136349000, 136350000, 136351000, 136352000, 136353000, 136354000, 136356000, 136358000, 136360000
- Where it went
- Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, Canada, Denmark, Finland, Germany, Greece, Guam, Hong Kong, Ireland, Netherlands, New Zealand, Norway, South Africa, Spain, Sweden, Switzerland, United Kingdom.
- How much
- 3488
VELYS Robotic-Assisted Solution Base Product No.: 451570100
Z-1029-2022 · Class II · reported 2022-05-11 · Terminated
- Why it was recalled
- System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause a delay in treatment
- Product
- VELYS Robotic-Assisted Solution Base Product No.: 451570100
- Where it went
- Worldwide distribution - US Nationwide and the countries of Israel, Australia & New Zealand.
- How much
- US: 68 units; OUS: 10 units
ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA)
Z-0631-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
- Product
- ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154909003
- Where it went
- US Nationwide distribution in the states of TN, TX.
- How much
- 6 units
ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revi
Z-0632-2022 · Class II · reported 2022-02-16 · Terminated
- Why it was recalled
- May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
- Product
- ATTUNE REVISION DISTAL FEMORAL AUGMENT SZ 6 4MM- Intended as a Component in total knee arthroplasty (TKA) revision surgeries Product Number: 154706001
- Where it went
- US Nationwide distribution in the states of TN, TX.
- How much
- 3 units
GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
Z-0487-2022 · Class II · reported 2022-01-19 · Terminated
- Why it was recalled
- Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- Product
- GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
- Where it went
- Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.
- How much
- 3 units
GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
Z-0490-2022 · Class II · reported 2022-01-19 · Terminated
- Why it was recalled
- Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- Product
- GLOBAL UNITE STD STEM SZ 16 Product Code: 110016100
- Where it went
- Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.
- How much
- 140 units
GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
Z-0486-2022 · Class II · reported 2022-01-19 · Terminated
- Why it was recalled
- Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- Product
- GLOBAL UNITE STD STEM SZ 10 Part Number: 110010100
- Where it went
- Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.
- How much
- 781 units
GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
Z-0488-2022 · Class II · reported 2022-01-19 · Terminated
- Why it was recalled
- Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- Product
- GLOBAL UNITE STD STEM SZ 12 Product Code: 110012100
- Where it went
- Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.
- How much
- 870 units
GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
Z-0485-2022 · Class II · reported 2022-01-19 · Terminated
- Why it was recalled
- Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- Product
- GLOBAL UNITE REV STEM SZ 8 Part Number: 110008600
- Where it went
- Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.
- How much
- 3 units
GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
Z-0489-2022 · Class II · reported 2022-01-19 · Terminated
- Why it was recalled
- Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- Product
- GLOBAL UNITE STD STEM SZ 14 Product Code: 110014100
- Where it went
- Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.
- How much
- 451 units
GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
Z-0483-2022 · Class II · reported 2022-01-19 · Terminated
- Why it was recalled
- Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- Product
- GLOBAL UNITE STD STEM SZ 6 Part Number: 11000610
- Where it went
- Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.
- How much
- 28 units
GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
Z-0484-2022 · Class II · reported 2022-01-19 · Terminated
- Why it was recalled
- Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
- Product
- GLOBAL UNITE STD STEM SZ 8 Part Number: 110008100
- Where it went
- Worldwide distribution - US Nationwide and the countries of Austria, Australia, Belgium, Canada, Denmark, Estonia, Finland, France, Germany, Greece, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, South Africa, Sweden, Switzerland, Thailand, United Kingdom.
- How much
- 432 units
ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
Z-0074-2022 · Class II · reported 2021-10-13 · Terminated
- Why it was recalled
- Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery
- Product
- ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
- Where it went
- US Nationwide distribution in the states of CA, LA, MN, MO, NC, NE, OR, PA, WA, WI.
- How much
- 10 units
TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific
Z-2398-2021 · Class II · reported 2021-09-08 · Terminated
- Why it was recalled
- Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
- Product
- TRUMATCH CT CUT GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420915
- Where it went
- Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.
- How much
- 5 cases ( 1/cs)
TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific
Z-2395-2021 · Class II · reported 2021-09-08 · Terminated
- Why it was recalled
- Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
- Product
- TRUMATCH CT PIN GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420579
- Where it went
- Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.
- How much
- 6 cases (1/Cs)
TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specif
Z-2397-2021 · Class II · reported 2021-09-08 · Terminated
- Why it was recalled
- Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
- Product
- TRUMATCH CT FEM CUT TIB PIN R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420907
- Where it went
- Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.
- How much
- 2 cases (1/cs)
TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific
Z-2396-2021 · Class II · reported 2021-09-08 · Terminated
- Why it was recalled
- Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
- Product
- TRUMATCH CT PIN GUIDE FEM R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420581
- Where it went
- Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.
- How much
- 2 cases (1 case)
TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific
Z-2400-2021 · Class II · reported 2021-09-08 · Terminated
- Why it was recalled
- Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
- Product
- TRUMATCH CT CUT GUIDE FEM L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420917
- Where it went
- Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.
- How much
- 1 cs (1/cs)
TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific
Z-2399-2021 · Class II · reported 2021-09-08 · Terminated
- Why it was recalled
- Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
- Product
- TRUMATCH CT CUT GUIDE KIT R- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420916
- Where it went
- Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.
- How much
- 9 cases (1/cs)
TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specifi
Z-2394-2021 · Class II · reported 2021-09-08 · Terminated
- Why it was recalled
- Software: A coding error associated with the Fast3D Segmentation software. During the scanning process the three images required of the hip, knee and ankle may not be aligned, causing the anatomic landmark locations to potentially result in limb malalignment.
- Product
- TRUMATCH CT PIN GUIDE KIT L- TruMatch Patient Specific Instruments are intended to be used as patient-specific surgical instrumentation to assist in the positioning of a joint replacement component intra-operatively and in guiding the marking of bone before cutting Part Number: 420578
- Where it went
- Distribution to US states of CA, CO, FL, IL, IN, NY, MI, MN, TX, and WA, Poland and UK.
- How much
- 4 cases (1/case)
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Z-2348-2021 · Class II · reported 2021-09-01 · Terminated
- Why it was recalled
- Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
- Product
- ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
- Where it went
- International distribution in the countries of Canada, France.
- How much
- 7 units
DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Nu
Z-1845-2021 · Class II · reported 2021-06-16 · Terminated
- Why it was recalled
- Fifty (50) individual units from Lot D20111130 were distributed with the incorrect part number and size etched on the product.
- Product
- DePuy Synthes Articul/eze Femoral Head: Hip joint metal/polymer semi-constrained cemented prosthesis. Part Number: 1365-21-000, Part Description: ARTICUL/EZE BALL 32 +1 GR
- Where it went
- Domestic: CA, CT, FL, GA, IA, IN, LA, ME, MN, MO, MT, NC, NE, NY, OH, OK, OR, PA, SC, TN, WI. Foreign: Bermuda
- How much
- 50 units
ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar co
Z-1314-2021 · Class II · reported 2021-04-07 · Terminated
- Why it was recalled
- Globally the company is removing 37 lots affected lots for MBT & ATTUNE (S+) Tibial Bases due to potential damaged packaging. These implant components are utilized in Total Knee Arthroplasty. The affected tibial bases are designed to be used in cemented applications.
- Product
- ATTUNE¿ FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.
- Where it went
- Worldwide distribution - US Nationwide distribution including in the states of AL, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, KS, KY, LA, MA, MD, ME, MI, MN, MO, MT, NC, NE, NH, NJ, NY, OH, OK, OR, PA, SC, TN, TX, VA, VT, WA, WI, WV and the countries of Brazil, Austria, Belgium, Denmark, Estonia, France, Germany, Great Britain, Ireland, Israel, Italy, Macedonia, Mauritius, Netherlands, Norway, Poland, Romania, Slovakia, Slovenia, South Africa, Sweden, Switzerland, United Arab Emirates, China, Hong Kong, Japan, New Zealand, Korea, Singapore, Thailand.
- How much
- 102 units total (Domestic: 6 units, Foreign: 86 units)
Showing the 30 most recent of 155. 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