Z-0084-2021 Class II Terminated
FDA device recall Z-0084-2021 was initiated by Biomet, Inc. on September 4, 2020 and is designated Class II. Reason for recall: Product not properly being aligned with the adequate gamma sterilization group and result in the product not being properly sterilized The recall status is terminated (terminated August 31, 2021). Affected quantity: 4 units OUS.
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
- 4 units OUS
Product Description
Biomet ARTHROSIMPLICITY KIT EU Item Number: 24-4055
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: 894660A 894660B 894670B 894700B