FDAJuly 26, 2016device
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.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
The outer packaging was mislabeled on the box indicating "Cobalt HV with Gentamicin". The bone cement does not contain antibiotics.
What to do
FDA enforcement status: Terminated
Brands named
encore medical lpencoreencore medical
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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