Encina HA Femoral Stem recalled over labeling errors
- Recall date
- October 9, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Signature Orthopaedics Europe Ltd recalls Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson…
- Recall number
- Z-1568-2020
- FDA classification
- Class II
- Brand / firm
- Signature Orthopaedics Europe Ltd
- Sold / distributed
- US: California
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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
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