Zimmer, Inc.: Medical Device Recall in 2023 - (Recall #: Z-1294-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

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

Product Classification:

Class II

Date Initiated: February 27, 2023

Date Posted: April 5, 2023

Recall Number: Z-1294-2023

Event ID: 91842

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

Status: Ongoing

Product Quantity: 1,168 untits

Code Information:

GTIN Number: 00889024283268 All lots

Distribution Pattern:

AL AZ CO FL LA MI OH OK TX Foreign: Canada

Voluntary or Mandated:

Voluntary: Firm initiated