Z-1960-2019 Class II Terminated

Recalled by Zimmer Biomet, Inc. — Warsaw, IN

Recall Details

Product Type
Devices
Report Date
July 24, 2019
Initiation Date
June 10, 2019
Termination Date
September 10, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
92

Product Description

Comprehensive Reverse Shoulder Instrument Case Outer (Outer Case Vault Only), Item Number 595509

Reason for Recall

Lack of an adequate sterilization validation.

Distribution Pattern

The products were distributed US nationwide. The products were distributed to the following foreign countries: Argentina, Australia, Canada, Chile, China, Columbia, Costa Rica, Ecuador, India, Japan, Korea, Malaysia, Mexico, Netherlands, Thailand, Venezuela.

Code Information

Lots: 262549 266083 1441011 M642860 2881015 3021022 3081051 266083 2591050 2771027 3231028 MJ54320 MJ54330 MJ54350 MJ54340