Zimmer Biomet Ceramic Hip Head 22.2 mm Lacks Stem Compatibility Information
Zimmer, Inc. is recalling a ceramic hip prosthesis head because the product labeling does not adequately describe compatibility with certain femoral stems used in hip replacement surgery.
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 product labeling without any reported injuries or illnesses. The hazard is a labeling deficiency that could affect proper device use, which qualifies as a moderate-severity documentation and instructional issue.
Plain-English summary
Zimmer, Inc. is recalling the Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203, a component used in hip replacement surgery. The recall affects 160 units distributed worldwide, including nationwide in the United States, Panama, Hong Kong, and China.
The product labeling does not adequately provide compatibility information for use of the ceramic femoral head with cobalt-chrome femoral stems or stainless-steel femoral stems. This gap in labeling documentation creates a risk that surgeons may use incompatible components together during hip replacement procedures.
Healthcare providers and patients who have received or may receive this device should contact Zimmer, Inc. for updated labeling and compatibility information before use. Patients with questions about their hip implant should consult their surgeon.
The recalled product
- Product
- Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +3 Neck, Model Number 802802203; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented or Non- Porous, Uncemented
- Manufacturer
- Zimmer, Inc.
- Hazard
- labeling-deficiency
- 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 00887868376368
- All lots distributed with IFU 87-6204-051-99 Rev D or prior
Distribution
Distributed nationwide across the United States.
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