Mako Surgical recalls

Mako Surgical appears in 27 official U.S. recall notices indexed by RecallRadar, most recently on 2022-09-21.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

• Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System
  FDA Device · Class II · 2022-09-21 · Mako Surgical
• Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.…
  FDA Device · Class II · 2020-11-25 · Mako Surgical
• Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
  FDA Device · Class II · 2020-08-12 · Mako Surgical
• 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
  FDA Device · Class II · 2019-06-26 · Mako Surgical
• 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
  FDA Device · Class II · 2019-06-26 · Mako Surgical
• Makoplasty RIO Standard System
  FDA Device · Class II · 2018-09-26 · Mako Surgical
• Stryker Mako Vizadisc Knee Procedure Tracking Kit
  FDA Device · Class II · 2018-09-05 · Mako Surgical
• Stryker Mako Vizadisc Hip Procedure Tracking Kit
  FDA Device · Class II · 2018-09-05 · Mako Surgical
• Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Inter…
  FDA Device · Class II · 2018-08-22 · Mako Surgical
• Restoris MCK Onlay Insert Extractor
  FDA Device · Class II · 2018-06-13 · Mako Surgical
• RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements
  FDA Device · Class II · 2018-05-16 · Mako Surgical
• Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providi…
  FDA Device · Class II · 2017-09-20 · Mako Surgical
• Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surg…
  FDA Device · Class II · 2017-09-20 · Mako Surgical
• MAKO RIO Standard System, internal cPCI Card CageP/N: 201337
  FDA Device · Class II · 2017-07-26 · Mako Surgical
• MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery
  FDA Device · Class II · 2017-03-15 · Mako Surgical
• Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components during acetabular re…
  FDA Device · Class II · 2017-02-22 · Mako Surgical
• MAKOplasty Hip Array Kit Laminate 150230
  FDA Device · Class II · 2016-05-11 · Mako Surgical
• RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular…
  FDA Device · Class II · 2016-05-04 · Mako Surgical
• Robotic Arm Interactive Orthopedic System (RIO)
  FDA Device · Class II · 2016-04-27 · Mako Surgical
• Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunct…
  FDA Device · Class II · 2016-03-09 · Mako Surgical
• Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector)
  FDA Device · Class II · 2015-11-11 · Mako Surgical
• Restoris Partial Knee Application (PKA) RIO (TGS 2.0)
  FDA Device · Class II · 2015-02-25 · Mako Surgical
• RESTORIS PST Acetabular Straight Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically…
  FDA Device · Class II · 2014-12-24 · Mako Surgical
• RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purp…
  FDA Device · Class II · 2014-12-24 · Mako Surgical
• RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically fo…
  FDA Device · Class II · 2014-12-24 · Mako Surgical
• Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic Syste…
  FDA Device · Class II · 2014-03-12 · Mako Surgical
• The RIO (TGS 2.), Model # MAKO TGS 2.0 (Part No. 204000)
  FDA Device · Class II · 2012-11-28 · Mako Surgical