Z-1568-2020 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- October 9, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 components
Product Description
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
Reason for Recall
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.
Distribution Pattern
US: California
Code Information
Lot # 7DD49-1