Drug recall
Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use…
FDA recall event 85121 · Class II · Signature Orthopaedics Europe Ltd
Key facts
| Event ID | 85121 |
|---|---|
| Recall numbers | Z-1568-2020 |
| Recalling firm | Signature Orthopaedics Europe Ltd |
| Product type | Devices |
| Products | 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)… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Oct 9, 2019 |
| Report date | Apr 1, 2020 |
| City | Athlone |
| Country | Ireland |
| FEI number | 3014763043 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: