Integra LifeSciences Corp. has recalled 128 units of the Duraform Dural Graft Implant (Size 3x3, Model 80-1477US) because they were found to have endotoxin levels that exceed safety specifications. Endotoxins are bacterial substances that can trigger severe inflammatory reactions if introduced into the body during surgery. No incidents or injuries have been reported to date for this specific lot.
Excessive endotoxin levels in surgical implants can cause serious immune responses, including fever, tissue inflammation, and other complications. This poses a significant health risk to patients undergoing neurological or spinal procedures where these graft implants are used.
Clinical Device Correction/Removal
Quantity: 128 units; Distributed in China.
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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