Zimmer Biomet Ceramic Hip Prosthesis Head Lacks Compatibility Labeling
Zimmer, Inc. is recalling a ceramic femoral head for hip prosthesis (Model 802802202, 22.2 mm) because product labeling does not adequately describe compatibility with certain metal femoral stems.
What this means for you
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 labeling information rather than a defect in the device itself or reported adverse events. The hazard is a labeling/compatibility information gap, not a structural or functional failure, and no illnesses or injuries are reported.
Plain-English summary
Zimmer, Inc. is recalling the Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck (Model Number 802802202) because the product labeling does not adequately provide compatibility information for use with cobalt-chrome femoral stems or stainless-steel femoral stems.
The recalled product consists of 158 units that were distributed worldwide, including US Nationwide and Panama, Hong Kong, and China. The recall affects all lots distributed with Instructions for Use (IFU) 87-6204-051-99 Rev D or prior (GTIN 00887868376351).
Patients who have received this prosthesis or healthcare providers who have implanted it should consult with Zimmer, Inc. or their physician regarding the adequacy of labeling information and any necessary follow-up care. Zimmer, Inc. is the recalling firm responsible for this medical device recall.
The recalled product
- Product
- Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
- Manufacturer
- Zimmer, Inc.
- Hazard
- labeling-incompleteness
- incompatibility-risk
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 00887868376351
- All lots distributed with IFU 87-6204-051-99 Rev D or prior
Distribution
Distributed nationwide across the United States.
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