medical Class II Updated 2020-04-01

Signature Orthopaedics Europe Ltd recalls Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-

Recalled 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


Hazard / Issue

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.

Issued by

FDA

Distribution: US: California
Lot/Code Info: Lot # 7DD49-1
View official government recall

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