Device recall
Z-1568-2020: Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V…
FDA device recall · Class II · Signature Orthopaedics Europe Ltd
Key facts
| Recall number (Z-number) | Z-1568-2020 |
|---|---|
| Recall event | 85121 |
| 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 |
| Product code | MEH |
| Recalling firm | Signature Orthopaedics Europe Ltd |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K161155 |
| FEI number | 3014763043 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database