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.
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. 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.
- Hazard
- mis-labeling
- incompatibility
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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