Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1645-2025·Announced 2025-04-30

Zimmer Biomet Ceramic Hip Prosthesis Head Lacks Stem Compatibility Information

Zimmer, Inc. is recalling a ceramic hip prosthesis head because its labeling does not adequately describe compatibility 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 involving a labeling deficiency—inadequate compatibility information—without reported illnesses or injuries. Labeling errors that do not describe a known hazard directly fall within the Moderate category per the rubric.

Plain-English summary

Zimmer, Inc. is recalling the Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202, a component used in hip replacement surgery. The product labeling does not adequately provide compatibility information for use with cobalt-chrome femoral stems or stainless-steel femoral stems.

Approximately 416 units of this device have been distributed worldwide, including to the United States, Panama, Hong Kong, and China. The recall affects all lots distributed with instructions for use (IFU) 87-6204-051-99 Rev D or prior.

Patients who have received this implant should consult with their surgeon or healthcare provider. Zimmer, Inc. is the manufacturer and recalling firm responsible for this recall.

The recalled product

Product: Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
Manufacturer: Zimmer, Inc.
Category: Medical Device — Hip Prosthesis Component
Hazard: mis-labeling
compatibility-information
Affected units: 416

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 00887868376320
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