Mako Surgical Corporation recalls
Every recall we track for Mako Surgical Corporation — 14 in all, from 2017–2022 — plus the complaints and injury reports the public filed about them. 1 is rated “stop using now”.
Recalls per year, by danger level
Recalls from Mako Surgical Corporation peaked in 2017 (5); 14 since 2017. 7% rated “stop using now”.
All FDA recall records for Mako Surgical Corporation since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 1 | 1 | 3 | 5 |
| 2018 | 1 | 0 | 2 | 1 | 4 |
| 2019 | 0 | 1 | 1 | 0 | 2 |
| 2020 | 0 | 0 | 2 | 0 | 2 |
| 2021 | 0 | 0 | 0 | 0 | 0 |
| 2022 | 0 | 0 | 1 | 0 | 1 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
Most common reasons for Mako Surgical Corporation recalls
What to do if you have a recalled Mako Surgical Corporation product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Mako Surgical Corporation recalls
11 shown- Lower riskMedical device
Mako Surgical Corporation recalls Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery
Stryker recalls USB Converter and Polaris Spectra Camera (Catalog #201148) due to potential infant failures causing non-function or error lights. Affected units may need replacement.
StrykerAug 8, 2022 - Lower riskMedical device
Mako Surgical Corporation recalls Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0
Mako Surgical recalls specific MICS Handpiece models with software versions THA 3.0 and later that may cause bone preparation errors during knee surgery. Affected units have serial numbers listed in the recall notice.
Mako SurgicalOct 23, 2020 - Lower riskMedical device
Mako Surgical Corporation recalls Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Mako Surgical recalls variable angle hip end effectors with catalog number 206967 due to potential bone preparation discrepancies during hip surgery.
MakoJul 9, 2020 - Lower riskMedical device
Mako Surgical Corporation recalls 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
Mako Surgical recalls 2.7 Degree Angled Sag: Ungreased bearings may cause malfunction during total knee surgery. Affected units have specific catalog and lot numbers.
MakoApr 25, 2019 - Lower riskMedical device
Mako Surgical Corporation recalls Stryker Mako Vizadisc Knee Procedure Tracking Kit
Stryker Mako recalls specific lots of Vizadisc Knee Procedure Tracking Kit due to reflective material damage causing camera detection issues. Affected units include catalog numbers 107120 with listed lot numbers.
Stryker MakoJul 24, 2018 - UnratedMedical device
Mako Surgical Corporation recalls Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with
Mako Surgical recalls Rio System Irrigation Clip (Catalog #111690) for out of tolerance risk in RESTORIS Partial Knee Application procedures. Affected lots include 176364, 178346, 181337, 185213, 186561, 189709, 190559, 193643, and 195763A1.
Mako SurgicalMay 10, 2018 - Stop using nowMedical device
Mako Surgical Corporation recalls Restoris MCK Onlay Insert Extractor.
Mako Surgical recalls Restoris MCK Onlay Insert Extractor with possible hinge pin disassociation. Affected items include specific lot numbers from 2019-2023. Stop using immediately if you own this surgical device.
Mako SurgicalJan 19, 2018 - UnratedMedical device
Mako Surgical Corporation recalls Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee
Mako Surgical recalls Makoplasty RIO Standard System (Ethernet to Fiber Optic Converter) due to communication-connection errors in partial knee surgery. Affected units include all lots for the Partial Knee Application.
Mako SurgicalDec 27, 2017 - Lower riskMedical device
Mako Surgical Corporation recalls RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Mako Surgical recalls RESTORIS MCK Tibial Baseplates with incorrect sizing labels that could lead to improper fit during knee replacement surgery. Affected items include specific sizes and lot numbers.
Mako SurgicalDec 1, 2017 - UnratedMedical device
Mako Surgical Corporation recalls Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is
Mako Surgical recalls Robotic Arm Interactive Orthopedic System (RIO) due to software not displaying all EE constants when screen is full. Affected units may have incomplete surgical guidance.
Mako SurgicalAug 7, 2017 - Use cautionMedical device
Mako Surgical Corporation recalls MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software
Mako Surgical recalls its RIO Standard System (P/N 201337) due to intermittent electrical issues that could cause power loss during orthopedic surgery. Affected units were sold with Lot No. 05212015.
Mako SurgicalJun 7, 2017
Mako Surgical Corporation recall questions
How many recalls has Mako Surgical Corporation had?
14 recalls from Mako Surgical Corporation are on record with U.S. safety agencies, from 2017–2022.
What is the most recent Mako Surgical Corporation recall?
Mako Surgical Corporation recalls Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery, dated Aug 8, 2022. Every Mako Surgical Corporation recall is listed on this page, newest first.
Why are Mako Surgical Corporation products recalled?
The most common reasons on record: The bearings of the saw attachments were ungreased. (2).
What should I do if I have a recalled Mako Surgical Corporation product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Mako Surgical Corporation recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.