TEI Biosciences recalls SurgiMend 3.0 collagen matrix products for soft tissue reconstruction due to potential endotoxin test failures in manufacturing. This is a prescription-only product with specific sizes and item numbers.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
TEI Biosciences is recalling SurgiMend 3.0 collagen matrix products for soft tissue reconstruction because they may have endotoxin test results that are out of specification. This could affect the safety of the product when used in medical procedures.
The recall is due to possible out of specification endotoxin test results in the manufacturing process. Endotoxins are bacterial components that can cause serious infections if they enter the body during surgery.
Prescription-only medical devices for soft tissue reconstruction. Patients using these products for surgical procedures are most at risk.
Check for the product name 'SurgiMend 3.0', sizes listed in the recall (e.g., 5x6 cm, 6x12 cm), and item numbers starting with 606-300-002 through 606-304-002 as listed in the recall notice.
Review the product name, sizes, and item numbers to confirm if your SurgiMend 3.0 collagen matrix is affected.
The recall indicates potential endotoxin test issues, but the official notice does not specify if the product is safe to use. You should check the product details to see if it's in the recall list.
The recall notice does not provide a remedy, so the official notice does not specify what action to take. Check the product details to see if it's affected.
Check the product name, sizes, and item numbers listed in the recall notice to see if they match the affected items.
We’ve drafted a message you can send TEI Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2074-2023 — TEI Biosciences TEI Biosciences Hello, I own a TEI Biosciences that is covered by recall Z-2074-2023 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.
