IsoTis OrthoBiologics, Inc. has recalled 145 units of OsteoCove Putty and Cove Putty because of a hydration issue with the polymer used in the products. This defect makes the putty less cohesive and harder to mold than intended during surgical procedures. No incidents or injuries have been reported related to this issue.
The polymer issue causes the product to be less moldable, which may prevent it from properly filling surgical voids or staying in place during a procedure. This could potentially lead to suboptimal surgical outcomes or complications during bone grafting.
Hydration issue resulting in less cohesive and moldable product.
Hydration issue resulting in less cohesive and moldable product.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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