Berkeley Advanced Biomaterials, LLC is recalling 62 units of its Tribio Implant 7.5mm x 40mm because the outer packaging identifies the incorrect product name. The Tribio Implant is a medical device used to fill bony voids or gaps in the skeletal system, such as in the extremities, pelvis, and spine, caused by surgery or traumatic injury. This voluntary recall was initiated after it was discovered that the product's outer box label was misprinted with a different product name.
The incorrect product name on the outer label could lead a healthcare provider to select and use an unintended implant during a surgical procedure. This error could cause surgical delays or suboptimal outcomes for patients if the mismatch is not identified before the device is used.
Indicated for use in bony voids or gaps of the skeletal system.
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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