Reported Apr 1, 2020 · Ongoing
Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson…
Signature Orthopaedics Europe Ltd.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Signature Orthopaedics Europe Ltd · Unit A, IDA Business & Technology Park · Athlone, N/A · N/A
Is this the product you have?
- 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
- Lot codes and dates
- Lot # 7DD49-1
- Amount recalled
- 5 components
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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