# FDA recall Z-1646-2025

> **Zimmer, Inc.** · Class II · device recall initiated 2025-03-24.

## Product

Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non-  Porous, Uncemented

## Reason for recall

The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.

## Distribution

Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong, China.

## Key facts

- **Recall number:** Z-1646-2025
- **Recalling firm:** Zimmer, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-03-24
- **Report date:** 2025-04-30

- **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-1646-2025

## Citation

> AI Analytics. FDA recall Z-1646-2025. Retrieved 2026-07-11 from https://api.ai-analytics.org/recall/Z-1646-2025. Source: US FDA. Licensed CC0.

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