Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1649-2025·Announced 2025-04-30

Zimmer Biomet Ceramic Hip Head 22.2 mm Lacks Stem Compatibility Information

Zimmer, Inc. is recalling a ceramic hip prosthesis head because the product labeling does not adequately describe compatibility with certain femoral stems used in hip replacement surgery.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving incomplete product labeling without any reported injuries or illnesses. The hazard is a labeling deficiency that could affect proper device use, which qualifies as a moderate-severity documentation and instructional issue.

Plain-English summary

Zimmer, Inc. is recalling the Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203, a component used in hip replacement surgery. The recall affects 160 units distributed worldwide, including nationwide in the United States, Panama, Hong Kong, and China.

The product labeling does not adequately provide compatibility information for use of the ceramic femoral head with cobalt-chrome femoral stems or stainless-steel femoral stems. This gap in labeling documentation creates a risk that surgeons may use incompatible components together during hip replacement procedures.

Healthcare providers and patients who have received or may receive this device should contact Zimmer, Inc. for updated labeling and compatibility information before use. Patients with questions about their hip implant should consult their surgeon.

The recalled product

Product: Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic Prosthesis / Hip Replacement
Hazard: labeling-deficiency
incompatibility
Affected units: 160

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

GTIN 00887868376368
All lots distributed with IFU 87-6204-051-99 Rev D or prior

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Zimmer, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Same manufacturer · Zimmer, Inc.

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Same hazard · labeling deficiency