TEI Biosciences recalls SurgiMend PRS collagen matrix products due to potential endotoxin test failures in manufacturing. This is a medical device for soft tissue reconstruction requiring a prescription.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
TEI Biosciences is recalling SurgiMend PRS collagen matrix products for soft tissue reconstruction because their endotoxin testing may be out of specification. This could affect medical safety during surgical procedures.
The products may have endotoxin test results that are out of specification due to issues with how the endotoxin testing was done during manufacturing. Endotoxins are bacterial components that can cause serious infections if they enter the body during surgery.
Patients and medical professionals who have prescription SurgiMend PRS collagen matrix products for soft tissue reconstruction are affected. Those using the products in surgical procedures are at risk.
Check for SurgiMend PRS collagen matrix products with sizes listed in the recall (e.g., 10x15 cm Semi-Oval, 7x17 cm Fenestrated). Look for the item numbers starting with 606-004-100 through 606-007-001 as listed in the recall notice.
Review the product's size and item number to confirm if it matches the recalled items listed in the recall notice.
The recall states there may be issues with endotoxin testing, but the product is not confirmed unsafe. Patients should contact the manufacturer for specific guidance.
The recall does not specify a remedy, so you should check with TEI Biosciences directly for instructions.
Check the product's size and item number against the list provided in the recall notice.
We’ve drafted a message you can send TEI Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2070-2023 — TEI Biosciences TEI Biosciences Hello, I own a TEI Biosciences that is covered by recall Z-2070-2023 from TEI Biosciences. 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.
