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Mako Surgical Corporation Recalls

17 recalls on record. Search official CPSC, FDA, and USDA datasets for every recall issued for Mako Surgical Corporation.

17Total Recalls
0Critical
5,389Units Affected
Oct 23, 2020Most Recent
All Recalls

Every Mako Surgical Corporation Recall

Sorted by most recent. Click any recall for full details.

17 recalls
High RiskFDA
Mako Surgical Corporation
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA ...
Medical Devices·367 affected·Oct 23, 2020
High RiskFDA
Mako Surgical Corporation
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
Medical Devices·12 affected·Jul 9, 2020
High RiskFDA
Mako Surgical Corporation
2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
Medical Devices·39 affected·Apr 25, 2019
High RiskFDA
Mako Surgical Corporation
Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA),...
Surgical Devices·736 affected·Dec 27, 2017
High RiskFDA
Mako Surgical Corporation
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Medical Devices·126 affected·Dec 1, 2017
High RiskFDA
Mako Surgical Corporation
Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist th...
Medical Devices·349 affected·Aug 7, 2017
High RiskFDA
Mako Surgical Corporation
Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in ...
Medical Devices·291 affected·Aug 7, 2017
High RiskFDA
Mako Surgical Corporation
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial bou...
Medical Devices·20 affected·Jun 7, 2017
High RiskFDA
Mako Surgical Corporation
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Medical Devices·777 affected·Dec 22, 2016
High RiskFDA
Mako Surgical Corporation
RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting aceta...
Medical Implants·96 affected·Feb 23, 2016
High RiskFDA
Mako Surgical Corporation
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in con...
Medical Devices·146 affected·Jan 15, 2016
High RiskFDA
Mako Surgical Corporation
MAKOplasty Hip Array Kit Laminate 150230
Medical Devices·10 affected·Nov 25, 2015
High RiskFDA
Mako Surgical Corporation
Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surg...
Surgical Devices·1,322 affected·Jul 16, 2015
High RiskFDA
Mako Surgical Corporation
RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the p...
Medical Implants·404 affected·Oct 7, 2014
High RiskFDA
Mako Surgical Corporation
RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically...
Medical Implants·404 affected·Oct 7, 2014
High RiskFDA
Mako Surgical Corporation
Robotic Arm Interactive Orthopedic System (RIO)
Medical Devices·249 affected·Apr 30, 2014
High RiskFDA
Mako Surgical Corporation
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic Sys...
Medical Implants·41 affected·Jan 9, 2014