TEI Biosciences recalls SurgiMend collagen matrix products due to potential endotoxin test failures in manufacturing. This affects specific sizes and item numbers. Consumers should check their product details and contact TEI for guidance.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
TEI Biosciences is recalling SurgiMend collagen matrix products for soft tissue reconstruction because endotoxin testing results may be out of specification. This could pose a risk of infection or other complications if used improperly.
The recall is due to possible issues with endotoxin testing during manufacturing. Endotoxins are bacterial components that can cause infections if present in medical products. Out of specification test results may indicate higher than safe levels of endotoxins.
Medical professionals who use SurgiMend for soft tissue reconstruction procedures are most at risk. Patients receiving this product under a prescription are also affected.
Check for product sizes listed in the recall: 5x6 cm, 6x12 cm, 10x10 cm, and others. Look for item numbers starting with 606-001-002 through 606-003-003.
Review the product size and item number to confirm if it matches the recalled items listed in the notice.
The recall indicates potential endotoxin test issues, but the product may still be safe for use if it passed all safety checks. Consult TEI Biosciences for specific guidance.
Check the product details against the recall list. If it matches, contact TEI Biosciences for further instructions.
Yes, specific sizes like 5x6 cm, 6x12 cm, 10x10 cm, and item numbers starting with 606-001-002 through 606-003-003 are affected.
We’ve drafted a message you can send TEI Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2069-2023 — TEI Biosciences TEI Biosciences Hello, I own a TEI Biosciences that is covered by recall Z-2069-2023 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.
