Home / Recalls / Mako Surgical Corporation / Z-2745-2020

Z-2745-2020 Class II Terminated

Recalled by Mako Surgical Corporation — Davie, FL

Recall Details

Product Type
Devices
Report Date
August 12, 2020
Initiation Date
July 9, 2020
Termination Date
June 16, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
12 units

Product Description

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

Reason for Recall

Characterization issue associated with the product. This issue may cause a discrepancy during bone preparation in certain Mako Total Hip procedures.

Distribution Pattern

TX, MN, CA, RI, FL, NY, AZ, TN

Code Information

UDI: (01)00848486022167(21)1905386; (01)00848486022167(21)1905389; (01)00848486022167(21)1905359; (01)00848486022167(21)1905352; (01)00848486022167(21)1905369; (01)00848486022167(21)1905387; (01)00848486022167(21)1905383; (01)00848486022167(21)1905353; (01)00848486022167(21)1905356; (01)00848486022167(21)1905357; (01)00848486022167(21)1905365; (01)00848486022167(21)1905388;

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  • Z-0472-2021 Class II — Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software (October 23, 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)