FDA Device recall 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
- FDA Device
- Class II
- ongoing
- Published 2020-04-01
On 2020-04-01 the FDA classified a Class II recall of Encina HA Femoral Stem, Size 11 Coxa Vara Collared, REF 100-30-011, Ti6AI4V Allow with HA Coating, For use with Stinson Orthopedics Inc by Signature Orthopaedics Europe, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1568-2020 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2019-10-09 |
| Published | 2020-04-01 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Signature Orthopaedics Europe |
| Distribution | CA |
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.
Identifiers
| code_info | Lot # 7DD49-1 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1568-2020%22
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