Z-1960-2019 Class II Terminated
FDA device recall Z-1960-2019 was initiated by Zimmer Biomet, Inc. on June 10, 2019 and is designated Class II. Reason for recall: Lack of an adequate sterilization validation. The recall status is terminated (terminated September 10, 2020). Affected quantity: 92.
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