Z-2348-2021 Class II Terminated
FDA device recall Z-2348-2021 was initiated by DePuy Orthopaedics, Inc. on July 1, 2021 and is designated Class II. Reason for recall: Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement The recall status is terminated (terminated February 1, 2023). Affected quantity: 7 units.
Recall Details
- Product Type
- Devices
- Report Date
- September 1, 2021
- Initiation Date
- July 1, 2021
- Termination Date
- February 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7 units
Product Description
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Reason for Recall
Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
Distribution Pattern
International distribution in the countries of Canada, France.
Code Information
Lot Number: J82N61 Expiry Date: 31May2030 GTIN: 10603295043010