Encore Medical Recalls Cobalt HV Bone Cement Due to Packaging Mislabeling
Encore Medical is recalling 866 units of Cobalt HV Bone Cement because the outer packaging incorrectly indicated the product contained Gentamicin, an antibiotic it does not contain.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 involves a minor labeling error regarding the presence of an antibiotic, which fits the criteria for moderate severity involving low-risk contamination or labeling issues.
Plain-English summary
Encore Medical, Lp is recalling 866 units of Cobalt HV Bone Cement. The product is a radiopaque, rapidly setting bone cement consisting of two separate, pre-measured, and sterilized components. The recall is due to a labeling error on the outer packaging, which incorrectly indicated that the product contained Gentamicin. The actual bone cement does not contain antibiotics.
The affected units are identified by Lot 507970. The product was distributed nationwide in the United States. This recall is classified as Class II by the FDA.
Healthcare providers and patients should stop using the affected product and contact Encore Medical, Lp for further instructions or a return.
The recalled product
- Product
- Cobalt HV Bone Cement Product Usage: Cobalt HV Bone Cement provides two separate, pre-measured and sterilized components which when mixed form a radiopaque, rapidly setting bone cement.
- Manufacturer
- Encore Medical, Lp
- Category
- Medical Device — Bone Cement
- Hazard
- Affected units
- 866
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 (1)
- Lot 507970
Distribution
Distributed nationwide across the United States.
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