# FDA recall Z-1568-2020

> **Signature Orthopaedics Europe Ltd** · Class II · device recall initiated 2019-10-09.

## 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.

## Distribution

US: California

## Key facts

- **Recall number:** Z-1568-2020
- **Recalling firm:** Signature Orthopaedics Europe Ltd
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2019-10-09
- **Report date:** 2020-04-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Athlone, N/A, Ireland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1568-2020

## Citation

> AI Analytics. FDA recall Z-1568-2020. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1568-2020. Source: US FDA. Licensed CC0.

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