Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1647-2025·Announced 2025-04-30

Zimmer Biomet Ceramic Hip Prosthesis Heads Lack Stem Compatibility Information

Zimmer, Inc. is recalling Zimmer Biomet Ceramic Head hip prostheses (Model 802802201, 22.2 mm diameter) because product labeling does not adequately provide 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. The source text identifies a labeling deficiency—inadequate compatibility information—but does not report any hospitalizations, injuries, or illnesses. The recall is precautionary to prevent potential incompatibility issues.

Plain-English summary

Zimmer, Inc. is recalling Zimmer Biomet Ceramic Head hip prostheses, 22.2 mm diameter, Type 1, -3 neck, Model Number 802802201. The product labeling does not adequately provide compatibility information for use with cobalt-chrome femoral stems or stainless-steel femoral stems.

Approximately 167 units have been distributed worldwide, including throughout the United States and to Panama, Hong Kong, and China. The affected product was distributed under GTIN 00887868376344 with Instructions for Use 87-6204-051-99 Revision D or earlier versions.

Patients with this prosthesis or healthcare providers who have implanted this device should consult with Zimmer, Inc. regarding proper stem compatibility before any revision surgery or if questions arise about the compatibility of the ceramic head with their femoral stem.

The recalled product

Product: Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Manufacturer: Zimmer, Inc.
Category: Medical Device — Orthopedic / Hip Prosthesis
Hazard: mis-labeling
incompatibility
Affected units: 167

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 00887868376344
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