Zimmer Biomet Hip Prosthesis Ceramic Head Lacks Stem Compatibility Labeling
Zimmer Biomet Ceramic Hip Prosthesis heads lack adequate labeling information for compatibility with certain femoral stems. This labeling deficiency affects 160 units distributed worldwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II recall for a risk-of-harm medical device where no injuries have been reported. Inadequate labeling regarding stem compatibility could result in implantation of incompatible femoral stem components, potentially leading to prosthesis failure or compromised function.
Plain-English summary
Zimmer, Inc. is recalling Zimmer Biomet Ceramic Head hip prostheses (Model 802802203, 22.2 mm Diameter, Type 1) due to inadequate labeling regarding compatibility with cobalt-chrome femoral stems or stainless-steel femoral stems. A total of 160 units have been affected, distributed worldwide including the United States, Panama, Hong Kong, and China.
The labeling deficiency could result in use of an incompatible femoral stem component, potentially affecting prosthesis function and stability. Proper stem selection is critical for optimal device performance and patient outcomes.
Healthcare providers and surgeons should verify stem compatibility and review product documentation before implantation. The U.S. Food and Drug Administration classified this as a Class II recall.
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
- inadequate-labeling
- device-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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