Home / Recalls / Mako Surgical Corporation / Z-1411-2017

Z-1411-2017 Class II Terminated

Recalled by Mako Surgical Corporation — Davie, FL

Recall Details

Product Type
Devices
Report Date
March 15, 2017
Initiation Date
December 22, 2016
Termination Date
August 6, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
777

Product Description

MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.

Reason for Recall

Five (5) AFMEA Risk Control Measures are missing from the MAKO RIO THA Application User Guides

Distribution Pattern

US nationwide distribution.

Code Information

Part Item #: 204863 - THA 1.0 Application User Guide Part Item #: 207116 - THA 2.0 Application User Guide Part Item #: 208692 - THA 2.1 Application User Guide Part Item #: 209711 - MAKOplasty THA Application User Guide Part Item #: 210555 - MAKIplast THA 3.1 Application User Guide Part Item#: 212026 - THA Application User Guide 2.1-2.1.1 THA 3.0, THA 3.1, 3.1.1 and 3.1.1.1 Part Item # 204863 THA 1.0 Application User Guide Part Item # 207116 THA 2.0 Application User Guide Part Item # 208692 THA 2.1 Application User Guide Part Item # 209711 MAKOplasty THA Application User Guide Part Item # 210555 MAKIplast THA 3.1 Application User Guide Part Item # 212026 THA Application User Guide

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  • 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)
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  • Z-2924-2018 Class II — Stryker Mako Vizadisc Knee Procedure Tracking Kit (July 24, 2018)
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  • 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)