Athlone, N/A, Ireland
Signature Orthopaedics Europe Ltd recalls
1 recall recorded since 2018, most recently on 9 October 2019. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 9 October 2019
- 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.
- Distribution
- US: California
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1568-2020
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.