Zimmer Biomet Recalls Cobalt Bone Cement Due to Packaging Seal Issues
Zimmer Biomet is recalling specific lots of Cobalt bone cement because a breach in the sterile Tyvek packaging could lead to loss of sterility.
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: The recall is classified as FDA Class II, and the hazard is a potential loss of sterility due to packaging breach. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 4,238 units of Cobalt HV Bone Cement, Cobalt MV Bone Cement, and Cobalt HV Bone Cement With Gentamicin. The recall involves specific model numbers and lot numbers, including 402282, 402282J, 402438, and 402283J.
The recall was initiated after six complaints were filed regarding the loss of the applied seal on the sterile Tyvek packaging. A breach in this packaging could lead to a loss of sterility for the medical device.
The affected products were distributed in Texas, Japan, and Mexico. Healthcare providers and facilities should check their inventory for the specific model and lot numbers listed in the recall notice and stop using any affected units.
The recalled product
- Product
- Cobalt HV Bone Cement Cobalt MV Bone Cement Cobalt HV Bone Cement With Gentamicin
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 4,238
Distribution
Distribution scope not specified by the agency.
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