Device product
Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc. Total Hip Replacement System Only, CEMENTLESS, UDI: (01) 00841176102934
Z-1568-2020
Product summary
- Event
- Event 85121
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5 components
- Official record key
device-enforcement:Z-1568-2020
Official wording
Reason: The firm has identified that packaging containing components of the hip replacement range are mislabeled. This could result in the product intended to be used for a procedure not included in the packaging resulting in a surgical delay.
Code information: Lot # 7DD49-1
Distribution pattern: US: California
Derived failure modes
-
Labeling or packaging
mislabeled