Home / Recalls / Mako Surgical Corporation / Z-1824-2019

Z-1824-2019 Class II Terminated

Recalled by Mako Surgical Corporation — Davie, FL

Recall Details

Product Type
Devices
Report Date
June 26, 2019
Initiation Date
April 25, 2019
Termination Date
April 22, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
7

Product Description

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

Reason for Recall

The bearings of the saw attachments were ungreased.

Distribution Pattern

AR, CA, FL, KS, MA, MO, NC, NJ, NY, OH, OR, TN, and TX. Australia, China and Netherlands

Code Information

Catalog Number: 212186 Lot Number: 35051018 and 35050918 UDI: (01)00848486032111(10)35051018 and (01)00848486032111(10)35050918

Other recalls by Mako Surgical Corporation

  • Z-1735-2022 Class II — Stryker USB Converter, Polaris Spectra Camera, Catalog #201148, a component of (August 8, 2022)
  • 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-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)