Recall Z-1568-2020— Signature Orthopaedics Europe Ltd
Class II · Ongoing
Class II FDA medical device recall by Signature Orthopaedics Europe Ltd, initiated 2019-10-09. It names one FDA 510(k) clearance: K161155. 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. Reason: 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..
- Recalling firm
- Signature Orthopaedics Europe Ltd
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2019-10-09
- Firm location
- Athlone, N/A, Ireland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.