Z-1294-2023 Class II Ongoing
FDA device recall Z-1294-2023 was initiated by Zimmer, Inc. on February 27, 2023 and is designated Class II. Reason for recall: Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the… The recall status is ongoing. Affected quantity: 1,168 untits.
Recall Details
- Product Type
- Devices
- Report Date
- April 5, 2023
- Initiation Date
- February 27, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,168 untits
Product Description
CoCr Femoral Head, XS, 38/-8, Taper 12/14-Intended to be used as a modular head component for articulation in total hip arthroplasty. Item Number: 01.01012.384
Reason for Recall
Update the compatibility matrix as referred to in the Instructions for Use (IFU) for the CoCr Femoral Head XS- removes the compatibility with the Epsilon Durasul Constrained Acetabular Liners from the matrix due to the range of motion in flexion/extension being less than 100 degrees as recommended per an internationally recognized standard (ISO 21535:2009
Distribution Pattern
AL AZ CO FL LA MI OH OK TX Foreign: Canada
Code Information
GTIN Number: 00889024283268 All lots