Signature Orthopaedics Europe Ltd: Medical Device Recall in 2020 - (Recall #: Z-1568-2020)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2020.
Data Source: FDA.
Product Description:
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
Product Classification:
Class II
Date Initiated: October 9, 2019
Date Posted: April 1, 2020
Recall Number: Z-1568-2020
Event ID: 85121
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.
Status: Ongoing
Product Quantity: 5 components
Code Information:
Lot # 7DD49-1
Distribution Pattern:
US: California
Voluntary or Mandated:
Voluntary: Firm initiated