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.
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 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.
- Hazard
- mis-labeling
- compatibility-information
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.
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