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Mako Surgical Corporation
Mako Surgical Corporation: 27 FDA recall reports
Every medical device recall the FDA has published for Mako Surgical Corporation. The fault, and how the agency graded it.
27Reports
0Class I
0Ongoing
2022-09-21Most recent
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.
Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted
Z-1735-2022 · Class II · reported 2022-09-21 · Terminated
- Why it was recalled
- Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.
- Product
- Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.
- Where it went
- US Distribution was made to IL and AZ.
- How much
- 2
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later,
Z-0472-2021 · Class II · reported 2020-11-25 · Completed
- Why it was recalled
- Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later). This issue may result in unsuccessful checkpoint verification when the Mako System attempts to verify the location of the saw blade prior to bone preparation. This issue may also cause a discrepancy during bone preparation in a Mako Total Knee or a Mako Partial Knee procedure in which the surgeon uses a straight or angled saw attachment with the MICS Handpiece. The surgeon may make cuts during bone preparation that differ from the surgeon s preoperative plan.
- Product
- Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).
- Where it went
- Worldwide distribution - US Nationwide distribution and the countries of Australia, Japan, Korea, Netherlands, and Chile, and France, Germany Luxembourg, and UK
- How much
- 367 units
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Z-2745-2020 · Class II · reported 2020-08-12 · Terminated
- Why it was recalled
- Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.
- Product
- Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
- Where it went
- TX, MN, CA, RI, FL, NY, AZ, TN
- How much
- 12 units
2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
Z-1823-2019 · Class II · reported 2019-06-26 · Terminated
- Why it was recalled
- The bearings of the saw attachments were ungreased.
- Product
- 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
- Where it went
- AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands
- How much
- 39
2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
Z-1824-2019 · Class II · reported 2019-06-26 · Terminated
- Why it was recalled
- The bearings of the saw attachments were ungreased.
- Product
- 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
- Where it went
- AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands
- How much
- 7
Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Part
Z-3182-2018 · Class II · reported 2018-09-26 · Terminated
- Why it was recalled
- Communication-connection error.
- Product
- Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include Unicondylar knee replacement and/or patellofemoral knee replacement.
- Where it went
- Worldwide Distribution - US Nationwide and the countries of Australia, New Zealand, Taiwan, China, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Germany, Ireland, Switzerland, Italy, India, Japan, South Korea, Vietnam, South Africa, and Turkey,
- How much
- 736 (US) and 174 (OUS)
Stryker Mako Vizadisc Knee Procedure Tracking Kit
Z-2924-2018 · Class II · reported 2018-09-05 · Terminated
- Why it was recalled
- Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.
- Product
- Stryker Mako Vizadisc Knee Procedure Tracking Kit
- Where it went
- All devices were distributed in the US in the following states: AK, AL, AR, AZ, CA, CO, CT, FL, IA, ID, KS, KY, LA, MA, MD, MI, MN, MO, NE, NC, NH, NJ, NY, NV, OH, PA, RI, SC, SD, TN. TX, UT, VA, WA, WI.
- How much
- 19,906 total devices
Stryker Mako Vizadisc Hip Procedure Tracking Kit
Z-2925-2018 · Class II · reported 2018-09-05 · Terminated
- Why it was recalled
- Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.
- Product
- Stryker Mako Vizadisc Hip Procedure Tracking Kit
- Where it went
- All devices were distributed in the US in the following states: AK, AL, AR, AZ, CA, CO, CT, FL, IA, ID, KS, KY, LA, MA, MD, MI, MN, MO, NE, NC, NH, NJ, NY, NV, OH, PA, RI, SC, SD, TN. TX, UT, VA, WA, WI.
- How much
- 19,906 total devices
Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) f
Z-2794-2018 · Class II · reported 2018-08-22 · Terminated
- Why it was recalled
- Out of tolerance.
- Product
- Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is indicated for use in surgical knee procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include unicondylar knee replacement and/or patellofemoral knee replacement.
- Where it went
- Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, Hong Kong, India, Italy, Korea, Midrand Allandale, Netherlands, Singapore, and United Kingdom
- How much
- 10,606
Restoris MCK Onlay Insert Extractor.
Z-2051-2018 · Class II · reported 2018-06-13 · Terminated
- Why it was recalled
- Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
- Product
- Restoris MCK Onlay Insert Extractor.
- Where it went
- Distributed domestically to AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, WI. Distributed internationally to Australia, China, Italy, Netherlands, Singapore, South Africa, Taiwan, Turkey, United Kingdom.
- How much
- 575 units total (400 US, 175 OUS)
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Z-1644-2018 · Class II · reported 2018-05-16 · Terminated
- Why it was recalled
- Incorrect product and/or label. Sizing is labeled incorrectly.
- Product
- RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
- Where it went
- AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OK, OR, PA, RI, SC, TX, UT, VA, WA, WY, and Hawaii Australia, Italy, Netherlands, Singapore, South Korea, United Kingdom, and Vietnam
- How much
- 126
Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RI
Z-3130-2017 · Class II · reported 2017-09-20 · Terminated
- Why it was recalled
- Software discrepancy of not showing all the EE constants, when the screen is filled.
- Product
- Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
- Where it went
- Worldwide - US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WY and the countries of Australia, Taiwan, China, Taiwan, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Ireland, Italy, Germany, India, Japan, Korea, Singapore, Thailand, Vietnam, South Africa, and Turkey
- How much
- 349 (US) and 78 (OUS)
Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intende
Z-3131-2017 · Class II · reported 2017-09-20 · Terminated
- Why it was recalled
- Software discrepancy of not showing all the EE constants, when the screen is filled.
- Product
- Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing software define spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures.
- Where it went
- Worldwide - US Nationwide Distribution in the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI and WY and the countries of Australia, Taiwan, China, Taiwan, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Ireland, Italy, Germany, India, Japan, Korea, Singapore, Thailand, Vietnam, South Africa, and Turkey
- How much
- 291 (US) and 66 (OUS)
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing s
Z-2741-2017 · Class II · reported 2017-07-26 · Terminated
- Why it was recalled
- An intermittent electrical problem that could lead to a loss of system power due to a loose screw connection.
- Product
- MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.
- Where it went
- Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA.
- How much
- 20
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Z-1411-2017 · Class II · reported 2017-03-15 · Terminated
- Why it was recalled
- Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides
- Product
- MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
- Where it went
- US nationwide distribution.
- How much
- 777
Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgic
Z-1193-2017 · Class II · reported 2017-02-22 · Terminated
- Why it was recalled
- Failure of the Offset Cup Reamer Handle not engaging its mating components.
- Product
- Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.
- Where it went
- Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV, & WY and the countries of Italy, Germany, Australia, China, Europe, Hong Kong, South Africa, Germany, Thailand & Singapore.
- How much
- 595 units
MAKOplasty Hip Array Kit Laminate 150230
Z-1588-2016 · Class II · reported 2016-05-11 · Terminated
- Why it was recalled
- Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.
- Product
- MAKOplasty Hip Array Kit Laminate 150230
- Where it went
- CO, KY, MN, WA and WV
- How much
- 10 units.
RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of posit
Z-1583-2016 · Class II · reported 2016-05-04 · Terminated
- Why it was recalled
- Potential disassociation of the orientation pin.
- Product
- RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
- Where it went
- Nationwide Distribution -- AL, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NY, OH, OK, OR, PA, RI, TN, TX, VA, WA, and WI.
- How much
- 96
Robotic Arm Interactive Orthopedic System (RIO)
Z-1508-2016 · Class II · reported 2016-04-27 · Terminated
- Why it was recalled
- Revision of the field manual
- Product
- Robotic Arm Interactive Orthopedic System (RIO)
- Where it went
- Worldwide Distribution - Nationwide Distribution and to the countries of : Australia, Italy, Japan, Hong Kong, Scotland, Germany, Turkey , Greece, Singapore, Taiwan and South Korea.
- How much
- 249
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental k
Z-1031-2016 · Class II · reported 2016-03-09 · Terminated
- Why it was recalled
- Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier.
- Product
- Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
- Where it went
- Worldwide Distribution: US (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, LA, MI, MS, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, and WY ; and countries of: Italy, Scotland, Turkey, Greece, Germany, and Singapore.
- How much
- 146
Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector).
Z-0224-2016 · Class II · reported 2015-11-11 · Terminated
- Why it was recalled
- The locking pin on the RIO Base Array is damaged during assembly onto the RIO Base Array Connector.
- Product
- Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee resurfacing and total hip Arthroplasty joint replacement procedures.
- Where it went
- Worldwide Distribution-US (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV, WY and HI, and the countries of Italy, Japan, Hong Kong, Scotland, Germany, Turkey, Greece, Australia, Singapore, Taiwan, and South Korea.
- How much
- 1,322 units
Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic
Z-1128-2015 · Class II · reported 2015-02-25 · Terminated
- Why it was recalled
- When using the MAKOplasty partial knee Arthroplasty application, the burr continues spinning outside of the stereotactic boundary and after the control switches (foot pedal and trigger) cease to be activated
- Product
- Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO), is indicated for use in surgical knee procedures.
- Where it went
- Nationwide Distribution-including the states of AK, AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, LA, MA, MD, MI, MO, MS, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WV and Hawaii.
- How much
- 228 units
RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surg
Z-0828-2015 · Class II · reported 2014-12-24 · Terminated
- Why it was recalled
- MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
- Product
- RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
- Where it went
- Nationwide Distribution including IL, OH, AZ, CO, GA, OK, NC, VA, CT, FL, CA, MA, NY, MI, VA, NH, TX, LA, WA, NJ, CA, RI, ID, TN, IN, WA, PA, and WI.
- How much
- Total 404
RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by ortho
Z-0830-2015 · Class II · reported 2014-12-24 · Terminated
- Why it was recalled
- MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
- Product
- RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
- Where it went
- Nationwide Distribution including IL, OH, AZ, CO, GA, OK, NC, VA, CT, FL, CA, MA, NY, MI, VA, NH, TX, LA, WA, NJ, CA, RI, ID, TN, IN, WA, PA, and WI.
- How much
- Total 404
RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for use by ort
Z-0829-2015 · Class II · reported 2014-12-24 · Terminated
- Why it was recalled
- MAKO has identified the potential that the shell impactors may be damaged intraoperatively.
- Product
- RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup components during Total Hip Arthroplasty (THA) surgery.
- Where it went
- Nationwide Distribution including IL, OH, AZ, CO, GA, OK, NC, VA, CT, FL, CA, MA, NY, MI, VA, NH, TX, LA, WA, NJ, CA, RI, ID, TN, IN, WA, PA, and WI.
- How much
- Total 404
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm
Z-1132-2014 · Class II · reported 2014-03-12 · Terminated
- Why it was recalled
- The product may be mislabeled and could result in the incorrect implant being used.
- Product
- Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). It is composed of a unicompartmental implant system (Restoris MCK Uni) and a patellofemoral implant system (Restoris MCK PF). The Restoris MCK Uni is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees. In Restoris MCK combination where multi-compartmental areas are being treated, the Restoris MCK components were designed with 3 mm of gap between the components to ensure that the components do not interfere. Is indicated for single or multi-compartmental knee replacement used in conjunction with RIO, in individuals with osteoarthritis or post-traumatic arthritis of the tibiofemoral and/or patellofemoral articular surfaces.
- Where it went
- Nationwide distribution including AZ, FL, HI, OH, MI, NC NH, WA, TX, WI, OK, CA, RI, LA, ID, IL, IN, and TN.
- How much
- 41 units
The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in prov
Z-0385-2013 · Class II · reported 2012-11-28 · Terminated
- Why it was recalled
- MAKO Surgical Group recalled their RIO System software, version 2.4 and is implementing software version 2.5 to address a software functional issue with the existing version of the system's software. Loss of tactile feedback constraining the cutting burr has been reported.
- Product
- The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is intended to assist the surgeon in providing software defined spatial boundaries for orientation and reference information to anatomical structures during orthopedic procedures. The RIO is indicated for use in surgical knee and hip procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy. These procedures include: Unicondylar knee replacement (UKA) and/or Patellofemoral knee replacement (PKA) and Total Hip Arthroplasty (THA).
- Where it went
- Worldwide Distribution - USA including IL, OR, IA, AZ, CA, CO, FL, MS, OK, PA, WV, NC, TX, NY, GA, NJ, OH, WA, VA, MA, MD, WI, MI, NV, MO, AL, UT, RI, AR, LA, ID, IN, and TN and Internationally to Japan, Scotland, Italy, Singapore, Turkey, Hong Kong, and Korea.
- How much
- 137 devices
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.
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