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FDAOctober 9, 2019device

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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.

What to do

FDA enforcement status: Ongoing

Brands named

signature orthopaedics europesignaturesignature orthopaedics

UPCs

00841176102934

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear