Mako Surgical Corporation recalls

22 recalls on record · latest: August 8, 2022

Official U.S. recall history for Mako Surgical Corporation, compiled from official government records.

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Mako Surgical Corporation recalls Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery Sy…

August 8, 2022 · Medical device recalls Moderate risk Certain units have the potential to exhibit infant failures whereby units eithe…

Mako Surgical Corporation recalls Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 a…

October 23, 2020 · Medical device recalls Moderate risk Stryker has discovered a characterization issue associated with the Mako Integr…

Mako Surgical Corporation recalls Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167

July 9, 2020 · Medical device recalls Moderate risk Characterization issue associated with the product. This issue may cause a disc…

Mako Surgical Corporation recalls 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)

April 25, 2019 · Medical device recalls Moderate risk The bearings of the saw attachments were ungreased.

Mako Surgical Corporation recalls 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)

April 25, 2019 · Medical device recalls Moderate risk The bearings of the saw attachments were ungreased.

Mako Surgical Corporation recalls Stryker Mako Vizadisc Knee Procedure Tracking Kit

July 24, 2018 · Medical device recalls Moderate risk Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Proc…

Mako Surgical Corporation recalls Stryker Mako Vizadisc Hip Procedure Tracking Kit

July 24, 2018 · Medical device recalls Moderate risk Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Proc…

Mako Surgical Corporation recalls Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with t…

May 10, 2018 · Medical device recalls Moderate risk Out of tolerance.

Mako Surgical Corporation recalls Restoris MCK Onlay Insert Extractor.

January 19, 2018 · Medical device recalls Moderate risk Possible hinge pin disassociation from the Mako Onlay Insert Extractor.

Mako Surgical Corporation recalls Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Appl…

December 27, 2017 · Medical device recalls Moderate risk Communication-connection error.

Mako Surgical Corporation recalls RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.

December 1, 2017 · Medical device recalls Moderate risk Incorrect product and/or label. Sizing is labeled incorrectly.

Mako Surgical Corporation recalls Makoplasty Partial Knee Application (PKA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intende…

August 7, 2017 · Medical device recalls Moderate risk Software discrepancy of not showing all the EE constants, when the screen is fi…

Mako Surgical Corporation recalls Total Hip Application (THA) Product Usage: The Robotic Arm Interactive Orthopedic System (RIO) is intended to assist th…

August 7, 2017 · Medical device recalls Moderate risk Software discrepancy of not showing all the EE constants, when the screen is fi…

Mako Surgical Corporation recalls MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. Intended to assist the surgeon in providing software defi…

June 7, 2017 · Medical device recalls Moderate risk An intermittent electrical problem that could lead to a loss of system power du…

Mako Surgical Corporation recalls MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.

December 22, 2016 · Medical device recalls Moderate risk Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Applicat…

Mako Surgical Corporation recalls Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only Product Usage: The handle is used to hold surgical components…

September 29, 2016 · Medical device recalls Moderate risk Failure of the Offset Cup Reamer Handle not engaging its mating components.

Mako Surgical Corporation recalls RESTORIS PST RIO Offset Shell Impactor For use by orthopedic surgeons specifically for the purpose of positioning and i…

February 23, 2016 · Medical device recalls Moderate risk Potential disassociation of the orientation pin.

Mako Surgical Corporation recalls Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacem…

January 15, 2016 · Medical device recalls Moderate risk Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell…

Mako Surgical Corporation recalls MAKOplasty Hip Array Kit Laminate 150230

November 25, 2015 · Medical device recalls Moderate risk Stryker Orthpaedics became aware that there is the potential for the 210540 MAK…

Mako Surgical Corporation recalls Robotic Arm Interactive Orthopedic (RIO) system component PN#205143 (locking pin) and PN# 112220 (connector). Indicated…

July 16, 2015 · Medical device recalls Moderate risk The locking pin on the RIO Base Array is damaged during assembly onto the RIO B…

Mako Surgical Corporation recalls Restoris Partial Knee Application (PKA) RIO (TGS 2.0). For use with the Robotic Arm Interactive Orthopedic System (RIO)…

January 22, 2015 · Medical device recalls Moderate risk When using the MAKOplasty partial knee Arthroplasty application, the burr conti…

Mako Surgical Corporation recalls Robotic Arm Interactive Orthopedic System (RIO)

April 30, 2014 · Medical device recalls Moderate risk Revision of the field manual