Zimmer Biomet Ceramic Head Hip Prosthesis Lacks Compatibility Information
Zimmer Biomet is recalling a ceramic hip prosthesis component due to inadequate labeling that does not specify compatibility with certain femoral stems. The missing compatibility information could lead to improper use during surgical implantation.
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 FDA Class II device recall involves a labeling deficiency with no reported injuries or illnesses. The hazard is theoretical—missing compatibility information could lead to improper use—but the risk has been addressed through the recall before documented harm occurred, fitting the criteria for moderate severity.
Plain-English summary
Zimmer Biomet Ceramic Head hip prosthesis components (Model 802602203, 22.2 mm diameter) are being recalled due to inadequate product labeling. The labeling does not adequately provide compatibility information for use with cobalt-chrome or stainless-steel femoral stems, which are commonly used in hip replacement procedures.
Approximately 215 units were distributed worldwide, including throughout the United States, Panama, Hong Kong, and China. These units can be identified by GTIN 00887868376337 and were distributed with Instruction for Use (IFU) 87-6204-051-99 Rev D or earlier versions.
The FDA classified this as a Class II medical device recall.
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
- inadequate-labeling
- incompatibility-risk
- component-compatibility
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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