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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
Recalled April 1, 2020 · FDA recall Z-1568-2020 · Signature Orthopaedics Europe
Hazard
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. · FDA Class II
Units
5 components
Sold at
US: California
Description
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.
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
Manufacturer(s)
Signature Orthopaedics Europe Ltd
Made in
Ireland
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →