Mako Surgical Corporation

Complete recall history across all FDA and CPSC categories — 27 total recalls

Mako Surgical Corporation appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (27)

FDA medical device enforcement actions by Mako Surgical Corporation

Date Product Reason Class
Aug 8, 2022 Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component ... Certain units have the potential to exhibit infant failures whereby units eit... Class II
Oct 23, 2020 Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Softw... Stryker has discovered a characterization issue associated with the Mako Inte... Class II
Jul 9, 2020 Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:008484860... Characterization issue associated with the product. This issue may cause a d... Class II
Apr 25, 2019 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and ... The bearings of the saw attachments were ungreased. Class II
Apr 25, 2019 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only) The bearings of the saw attachments were ungreased. Class II
Jul 24, 2018 Stryker Mako Vizadisc Hip Procedure Tracking Kit Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Pr... Class II
Jul 24, 2018 Stryker Mako Vizadisc Knee Procedure Tracking Kit Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Pr... Class II
May 10, 2018 Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS... Out of tolerance. Class II
Jan 19, 2018 Restoris MCK Onlay Insert Extractor. Possible hinge pin disassociation from the Mako Onlay Insert Extractor. Class II
Dec 27, 2017 Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 2... Communication-connection error. Class II
Dec 1, 2017 RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplast... Incorrect product and/or label. Sizing is labeled incorrectly. Class II
Aug 7, 2017 Total Hip Application (THA) Product Usage: The Robotic Arm Interactive O... Software discrepancy of not showing all the EE constants, when the screen is ... Class II
Aug 7, 2017 Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm ... Software discrepancy of not showing all the EE constants, when the screen is ... Class II
Jun 7, 2017 MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to ... An intermittent electrical problem that could lead to a loss of system power ... Class II
Dec 22, 2016 MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic ... Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Applic... Class II
Sep 29, 2016 Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: ... Failure of the Offset Cup Reamer Handle not engaging its mating components. Class II
Feb 23, 2016 RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons spec... Potential disassociation of the orientation pin. Class II
Jan 15, 2016 Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated fo... Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshe... Class II
Nov 25, 2015 MAKOplasty Hip Array Kit Laminate 150230 Stryker Orthpaedics became aware that there is the potential for the 210540 M... Class II
Jul 16, 2015 Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking ... The locking pin on the RIO Base Array is damaged during assembly onto the RIO... Class II
Jan 22, 2015 Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Ro... When using the MAKOplasty partial knee Arthroplasty application, the burr con... Class II
Oct 7, 2014 RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable i... MAKO has identified the potential that the shell impactors may be damaged int... Class II
Oct 7, 2014 RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable ins... MAKO has identified the potential that the shell impactors may be damaged int... Class II
Oct 7, 2014 RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument de... MAKO has identified the potential that the shell impactors may be damaged int... Class II
Apr 30, 2014 Robotic Arm Interactive Orthopedic System (RIO) Revision of the field manual Class II
Jan 9, 2014 Restoris Multicompartmental Knee (MCK) System is an implant system designed t... The product may be mislabeled and could result in the incorrect implant being... Class II
Sep 12, 2012 The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000). The RIO is inten... MAKO Surgical Group recalled their RIO System software, version 2.4 and is im... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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