Mako Surgical Corporation
20 recalls on record · Latest: Nov 25, 2020
FDA Devices Moderate Nov 25, 2020
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 - Produc…
FDA Devices Moderate Aug 12, 2020
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
FDA Devices Moderate Jun 26, 2019
2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
FDA Devices Moderate Sep 26, 2018
Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use wit…
FDA Devices Moderate Sep 5, 2018
Stryker Mako Vizadisc Knee Procedure Tracking Kit
FDA Devices Moderate Jun 13, 2018
Restoris MCK Onlay Insert Extractor.
FDA Devices Moderate May 16, 2018
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
FDA Devices Moderate Sep 20, 2017
Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in…
FDA Devices Moderate Sep 20, 2017
Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing so…
FDA Devices Moderate Jul 26, 2017
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defined spatial boundaries duri…
FDA Devices Moderate Mar 15, 2017
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
FDA Devices Moderate May 11, 2016
MAKOplasty Hip Array Kit Laminate 150230
FDA Devices Moderate May 4, 2016
RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and implanting acetabular cup co…
FDA Devices Moderate Apr 27, 2016
Robotic Arm Interactive Orthopedic System (RIO)
FDA Devices Moderate Mar 9, 2016
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction wit…
FDA Devices Moderate Nov 11, 2015
Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated for use in surgical knee re…
FDA Devices Moderate Dec 24, 2014
RESTORIS PST Straight Shell Inserter An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the purpose of po…
FDA Devices Moderate Dec 24, 2014
RESTORIS PST Acetabular Offset Shell Impactors An impactor is a reusable instrument designed for use by orthopedic surgeons specifically for the pur…
FDA Devices Moderate Mar 12, 2014
Restoris Multicompartmental Knee (MCK) System is an implant system designed to be used with MAKO's Robotic Arm Interactive Orthopedic System (RIO). I…
FDA Devices Moderate Nov 28, 2012