# FDA recall Z-1294-2023

> **Zimmer, Inc.** · Class II · device recall initiated 2023-02-27.

## Product

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

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

## Key facts

- **Recall number:** Z-1294-2023
- **Recalling firm:** Zimmer, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-02-27
- **Report date:** 2023-04-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Warsaw, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1294-2023

## Citation

> AI Analytics. FDA recall Z-1294-2023. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-1294-2023. Source: US FDA. Licensed CC0.

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