Home / Recalls / Mako Surgical Corporation / Z-1588-2016

Z-1588-2016 Class II Terminated

Recalled by Mako Surgical Corporation — Plantation, FL

Recall Details

Product Type
Devices
Report Date
May 11, 2016
Initiation Date
November 25, 2015
Termination Date
August 25, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10 units.

Product Description

MAKOplasty Hip Array Kit Laminate 150230

Reason for Recall

Stryker Orthpaedics became aware that there is the potential for the 210540 MAKOplasty Hip Array Kit Laminate 150230 to list two part numbers for the RIO Base Array, which is item #5 on the product table.

Distribution Pattern

CO, KY, MN, WA and WV

Code Information

Catalog No. 210540, Lot Code: 150324

Other recalls by Mako Surgical Corporation

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  • 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)