# FDA recall Z-1538-2018

> **Zimmer Biomet, Inc.** · Class II · device recall initiated 2018-04-02.

## Product

Modular Head Component, Biomet Hip System; Item No. 11-363661, Hip Joint, metal/polymer/metal, semi-constrained, porous-coated, uncemented prosthesis     The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.

## Reason for recall

Two lots of different sized modular heads potentially commingled. Risks include delay in surgery and dislocation due to use of an incorrect sized head.

## Distribution

Worldwide Distribution: US (nationwide) in states of: AL, AR, FL, GA, IN, KY, LA, MO, MS, OH, OK, TX, and VA; and countries of: Canada, Costa Rica and Chile.

## Key facts

- **Recall number:** Z-1538-2018
- **Recalling firm:** Zimmer Biomet, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-02
- **Report date:** 2018-05-09
- **Termination date:** 2020-05-12

- **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-1538-2018

## Citation

> AI Analytics. FDA recall Z-1538-2018. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1538-2018. Source: US FDA. Licensed CC0.

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