Mako Surgical Corporation
Davie, FL
This page shows every FDA and USDA recall linked to Mako Surgical Corporation. Each entry includes the product involved, when the recall happened, and how serious it was. If a company has had multiple recalls over the years, you can see the full history here in one place — including whether any were Class I, which is the most serious type.
19
Total Recalls
2008
First Recall
2020
Most Recent
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later,...
Nov 19, 2020
· Device
Completed
Mako Hip End Effector, Variable Angle
Catalog Number: 206967
GTIN:00848486022167
Jul 31, 2020
· Device
Terminated
2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
Apr 25, 2019
· Device
Terminated
2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
Apr 25, 2019
· Device
Terminated
Stryker Mako Vizadisc Hip Procedure Tracking Kit
Aug 24, 2018
· Device
Terminated
Stryker Mako Vizadisc Knee Procedure Tracking Kit
Aug 24, 2018
· Device
Terminated
Restoris MCK Onlay Insert Extractor.
Jun 1, 2018
· Device
Terminated
Rio System Irrigation Clip - Catalog # 111690
Product Usage:
The RESTORIS Partial Knee Application (PKA) for...
May 10, 2018
· Device
Terminated
Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933
Product Usage:
The Partial...
Dec 27, 2017
· Device
Terminated
RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.
Dec 1, 2017
· Device
Terminated
Total Hip Application (THA)
Product Usage:
The Robotic Arm Interactive Orthopedic System (RIO) is intended t...
Aug 7, 2017
· Device
Terminated
Makoplasty Partial Knee Application (PKA)
Product Usage:
The Robotic Arm Interactive Orthopedic System (RIO)...
Aug 7, 2017
· Device
Terminated
MAKO RIO Standard System, internal cPCI Card CageP/N: 201337.
Intended to assist the surgeon in providing sof...
Jun 7, 2017
· Device
Terminated
MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.
Dec 22, 2016
· Device
Terminated
Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only
Product Usage:
The handle is used to hold surgical...
Sep 29, 2016
· Device
Terminated
Labeling for RIO Robot Unit is comprised of three main components: 20399 RIO SURGICAL ARM, 201251 RIO GUIDANCE...
Nov 1, 2011
· Device
Terminated
MAKO PN 204588 Camera
204588 Label With Camera Stand Number ***PN 200294 SN CAM XXX 2011-01.*** Weight 86.2kg...
May 20, 2011
· Device
Terminated
200996-Cable Assembly, Hybrid Extended Length,
200997 Cable Assembly, Hybrid, Guidance Module,
200998 Cable A...
Oct 19, 2009
· Device
Terminated
Tibial Array and Femoral Array.
Model Number(s): 0150ARR00001 and 0150ARR00002.
Manufactured by: MAKO Surgica...
Feb 11, 2009
· Device
Terminated