Davie, FL, United States

Mako Surgical Corporation recalls

9 recalls recorded since 2018, most recently on 8 August 2022. None are listed as ongoing. Status and classification are as published by the FDA.

Recalls9

Ongoing (FDA)0

Terminated or completed9

Class I (FDA)0

Recall started: 8 August 2022
Terminated: 22 May 2026
Reason: Certain units have the potential to exhibit infant failures whereby units either arrive non-functional, have the potential to become non-functional, or flash an error light while in use.
Distribution: US Distribution was made to IL and AZ.
Initiated: Voluntary: Firm initiated
Recall number: Z-1735-2022

Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of the Mako Robotic-Arm Assisted Surgery System.

Recall started: 23 October 2020
Reason: Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later). This issue may result in unsuccessful checkpoint verification when the Mako System attempts to verify the location of the saw blade prior to bone preparation. This issue may also cause a discrepancy during bone preparation in a Mako Total Knee or a Mako Partial Knee procedure in which the surgeon uses a straight or angled saw attachment with the MICS Handpiece. The surgeon may make cuts during bone preparation that differ from the surgeon s preoperative plan.
Distribution: Worldwide distribution - US Nationwide distribution and the countries of Australia, Japan, Korea, Netherlands, and Chile, and France, Germany Luxembourg, and UK
Initiated: Voluntary: Firm initiated
Recall number: Z-0472-2021

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 - Product Usage: The MICS Handpiece is attached to the distal end of the roboti

Recall started: 9 July 2020
Terminated: 16 June 2023
Reason: Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.
Distribution: TX, MN, CA, RI, FL, NY, AZ, TN
Initiated: Voluntary: Firm initiated
Recall number: Z-2745-2020

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

Recall started: 25 April 2019
Terminated: 22 April 2021
Reason: The bearings of the saw attachments were ungreased.
Distribution: AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands
Initiated: Voluntary: Firm initiated
Recall numbers: Z-1823-2019, Z-1824-2019

2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only)
2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)

Recall started: 24 July 2018
Terminated: 11 October 2022
Reason: Specific lots of the Vizadisc Knee Procedure Tracking Kit and Vizadisc Hip Procedure Tracking Kit have the potential to be damaged on the Vizadisc reflective material causing an inability to be detected by the camera.
Distribution: All devices were distributed in the US in the following states: AK, AL, AR, AZ, CA, CO, CT, FL, IA, ID, KS, KY, LA, MA, MD, MI, MN, MO, NE, NC, NH, NJ, NY, NV, OH, PA, RI, SC, SD, TN. TX, UT, VA, WA, WI.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2924-2018, Z-2925-2018

Recall started: 10 May 2018
Terminated: 17 January 2021
Reason: Out of tolerance.
Distribution: Worldwide Distribution - US Nationwide in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NH, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, WI, WY and the countries of Australia, Hong Kong, India, Italy, Korea, Midrand Allandal
Initiated: Voluntary: Firm initiated
Recall number: Z-2794-2018

Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Partial Knee Application (PKA) for use with the Robotic Arm Interactive Orthopedic System (RIO) is intended to assist the surgeon in providing

Recall started: 19 January 2018
Terminated: 16 September 2020
Reason: Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
Distribution: Distributed domestically to AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, WI. Distributed internationally to Australia, China, Italy, Netherlands, Singapore, South Africa, Taiwan, Turkey, United Kingdom.
Initiated: Voluntary: Firm initiated
Recall number: Z-2051-2018

Recall started: 27 December 2017
Terminated: 14 December 2020
Reason: Communication-connection error.
Distribution: Worldwide Distribution - US Nationwide and the countries of Australia, New Zealand, Taiwan, China, Hong Kong, Greece, United Kingdom, England, Netherlands, Luxembourg, Germany, Ireland, Switzerland, Italy, India, Japan, South Korea, Vietnam, South Africa, and Turkey,
Initiated: Voluntary: Firm initiated
Recall number: Z-3182-2018

Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 200933 Product Usage: The Partial Knee Application (PKA), for use with the Mako System, is indicated for use in surgical knee procedures, in

Recall started: 1 December 2017
Terminated: 14 December 2020
Reason: Incorrect product and/or label. Sizing is labeled incorrectly.
Distribution: AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OK, OR, PA, RI, SC, TX, UT, VA, WA, WY, and Hawaii Australia, Italy, Netherlands, Singapore, South Korea, United Kingdom, and Vietnam
Initiated: Voluntary: Firm initiated
Recall number: Z-1644-2018

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

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.