Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Encina HA Femoral Stem Recalled by Signature Orthopaedics Europe Ltd Due to Mislabeling

Date: October 9, 2019
Company: Signature Orthopaedics Europe Ltd
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Signature Orthopaedics Europe Ltd directly.

Affected 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) 00841176102934

Quantity: 5 components

Why Was This Recalled?

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.

Where Was This Sold?

US: California

About Signature Orthopaedics Europe Ltd

Signature Orthopaedics Europe Ltd has 1 total recall tracked by RecallDetector.

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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report