Zimmer Biomet Hip Prosthesis Ceramic Head Lacks Compatibility Information
Zimmer, Inc. is recalling ceramic hip prosthesis heads (22.2 mm diameter) because product labeling does not adequately specify compatibility with cobalt-chrome or stainless-steel 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 Class II medical device recall is a labeling issue—the product information does not adequately specify compatibility with certain femoral stems. With no reported injuries and the primary concern being incomplete documentation rather than a device defect, this falls within Moderate severity.
Plain-English summary
Zimmer, Inc. is recalling 167 units of the Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck (Model Number 802802201), a component used in hip prosthesis systems.
The recall is due to inadequate compatibility information in the product labeling. Specifically, the labeling does not adequately provide guidance regarding compatibility for use with cobalt-chrome femoral stems or stainless-steel femoral stems.
The affected devices have been distributed worldwide, including throughout the United States and to Panama, Hong Kong, and China. All units distributed with instructions for use 87-6204-051-99 Rev D or prior versions are included in this recall.
Healthcare providers and patients should contact Zimmer, Inc. for updated labeling with appropriate compatibility information.
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.
- Hazard
- mis-labeling
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.
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