Zimmer Biomet Ceramic Hip Prosthesis Head Lacks Stem Compatibility Information
Zimmer, Inc. is recalling a ceramic hip prosthesis head because its labeling does not adequately describe compatibility 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 involving a labeling deficiency—inadequate compatibility information—without reported illnesses or injuries. Labeling errors that do not describe a known hazard directly fall within the Moderate category per the rubric.
Plain-English summary
Zimmer, Inc. is recalling the Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202, a component used in hip replacement surgery. The product labeling does not adequately provide compatibility information for use with cobalt-chrome femoral stems or stainless-steel femoral stems.
Approximately 416 units of this device have been distributed worldwide, including to the United States, Panama, Hong Kong, and China. The recall affects all lots distributed with instructions for use (IFU) 87-6204-051-99 Rev D or prior.
Patients who have received this implant should consult with their surgeon or healthcare provider. Zimmer, Inc. is the manufacturer and recalling firm responsible for this recall.
The recalled product
- Product
- Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; 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 00887868376320
- All lots distributed with IFU 87-6204-051-99 Rev D or prior
Distribution
Distributed nationwide across the United States.
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