Device product
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Z-2348-2021
Product summary
- Event
- Event 88413
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 units
- Official record key
device-enforcement:Z-2348-2021
Official wording
Reason: Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
Code information: Lot Number: J82N61 Expiry Date: 31May2030 GTIN: 10603295043010
Distribution pattern: International distribution in the countries of Canada, France.
Derived failure modes
-
Unknown
Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement