Encina HA Femoral Stem — Class II medical device recall Z-1568-2020
Ongoing recall by Signature Orthopaedics Europe Ltd, reported 2020-04-01, distributed in CA. The firm has identified that packaging containing components of the hip replacement range are mislabeled. This
| Recall number | Z-1568-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Signature Orthopaedics Europe Ltd, Athlone, N/A, Ireland |
| Recall initiated | 2019-10-09 |
| Classified | 2020-03-25 |
| Reported by FDA | 2020-04-01 |
| Distributed | CA |
| Quantity | 5 components |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00841176102934 |
| Lot numbers | 7DD49-1 |
| Model numbers | 100-30-011, TI6AI4V |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1568-2020. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.