Z-0081-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 14, 2020
- Initiation Date
- September 4, 2020
- Termination Date
- August 31, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- US: 62 units; OUS: 176 units
Product Description
Biomet Regenerex Primary Taper Cap Item Number 141269
Reason for Recall
Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized
Distribution Pattern
Nationwide Foreign: Canada, FINLAND, NETHERLANDS, UNITED KINGDOM
Code Information
Lot Numbers: 015800 324440 685300 023900 324440R 696280 058930 389060 821980 200720 418430 890320 313260 646040 997610