Home / Recalls / Mako Surgical Corporation / Z-1735-2022

Z-1735-2022 Class II Ongoing

Recalled by Mako Surgical Corporation — Weston, FL

Recall Details

Product Type
Devices
Report Date
September 21, 2022
Initiation Date
August 8, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2

Product Description

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

Reason for Recall

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 Pattern

US Distribution was made to IL and AZ.

Code Information

Lot #22041607, UDI-DI (GTIN) 07613327407280.

Other recalls by Mako Surgical Corporation

  • Z-0472-2021 Class II — Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software (October 23, 2020)
  • Z-2745-2020 Class II — Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:008484860221 (July 9, 2020)
  • Z-1823-2019 Class II — 2.7 Degree Angled Sagittal Saw attachment (Mako Total Knee Application Only) (April 25, 2019)
  • Z-1824-2019 Class II — 2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Par (April 25, 2019)
  • Z-2924-2018 Class II — Stryker Mako Vizadisc Knee Procedure Tracking Kit (July 24, 2018)
  • Z-2925-2018 Class II — Stryker Mako Vizadisc Hip Procedure Tracking Kit (July 24, 2018)
  • Z-2794-2018 Class II — Rio System Irrigation Clip - Catalog # 111690 Product Usage: The RESTORIS Pa (May 10, 2018)
  • Z-2051-2018 Class II — Restoris MCK Onlay Insert Extractor. (January 19, 2018)
  • Z-3182-2018 Class II — Makoplasty RIO Standard System; Ethernet to Fiber Optic Converter Catalog # 2009 (December 27, 2017)
  • Z-1644-2018 Class II — RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty a (December 1, 2017)