Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1646-2025·Announced 2025-04-30

Zimmer Biomet Ceramic Femoral Head Hip Prosthesis Labeling Recall

Zimmer, Inc. is recalling a ceramic femoral head hip prosthesis (Model 802602203) because product labeling lacks compatibility information for use with cobalt-chrome or stainless-steel femoral stems.

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 for a labeling deficiency—specifically, inadequate compatibility information. The source text does not report any illnesses, injuries, or failures, and the hazard is labeling-related rather than a direct device malfunction. Per the rubric, labeling errors and precautionary recalls fall into the Moderate (2) category.

Plain-English summary

Zimmer, Inc. is recalling the Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck (Model Number 802602203) hip prosthesis. The product is distributed worldwide, including US Nationwide and in Panama, Hong Kong, and China. A total of 215 units have been distributed.

The recall is due to inadequate labeling. The product documentation does not provide sufficient compatibility information for use of the 22.2 mm diameter ceramic femoral heads with cobalt-chrome femoral stems or stainless-steel femoral stems.

Patients and healthcare providers who have received or implanted this product should contact Zimmer, Inc. for updated labeling and compatibility guidance. This is a Class II medical device recall issued by the FDA.

The recalled product

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
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic / Hip Prosthesis
Hazard: mis-labeling
compatibility-information
Affected units: 215

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 00887868376337
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 · mis labeling