Integra LifeSciences recalls specific Duraform Dural Graft Implant (Model 80-147: Lot CT007694) due to potential endotoxin levels outside specifications. Affected patients should contact for guidance.
Out of specification endotoxin levels.
Integra LifeSciences is recalling a specific Dura: 3x3 size, Model 80-1477US, Lot CT007694. The recall is due to endotoxin levels that may be outside safe specifications, which could pose a risk during medical procedures.
Endotoxins are natural components of bacterial cell walls. If present in excessive amounts, they can cause severe reactions like fever, shock, or organ damage during medical procedures.
Patients who received this specific implant during surgery are likely affected. Medical professionals using this implant for procedures are at higher risk.
Check for the model number 80-1477US and lot number CT007694 on the implant packaging or documentation. This specific batch was produced in a particular facility and used in surgeries.
Reach out to Integra LifeSciences directly for guidance on next steps regarding the recalled implant.
The recall indicates potential endotoxin levels outside specifications, which could pose a risk during medical procedures. Affected patients should contact Integra LifeSciences for guidance.
Contact Integra LifeSciences directly for specific instructions related to your implant.
Check for the model number 80-1477US and lot number CT007694 on the implant packaging or documentation.
We’ve drafted a message you can send Integra LifeSciences to request your refund or repair — edit it as you like.
Subject: Recall Z-0262-2025 — Integra LifeSciences Integra LifeSciences Hello, I own a Integra LifeSciences that is covered by recall Z-0262-2025 from Integra LifeSciences. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
