TEI Biosciences recalls SurgiMend 4.0 collagen matrix products due to potential endotoxin test failures in manufacturing. This is a prescription-only medical device for soft tissue reconstruction.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
TEI Biosciences is recalling SurgiMend 4.0 collagen matrix products for soft tissue reconstruction because their endotoxin testing may have been inaccurate. This could affect medical safety during surgical procedures.
The recall is for possible issues with endotoxin testing during manufacturing. Endotoxins are bacterial components that could cause infections if present in medical devices. Inaccurate testing might mean harmful levels are in the product.
Patients prescribed SurgiMend 4.0 by doctors for soft tissue reconstruction are affected. Medical professionals using these products during surgery are at highest risk.
Check for SurgiMend 4.0 collagen matrix products with sizes 5x6 cm, 6x12 cm, 10x15 cm, 13x25 cm, or other listed sizes. The product has a unique identifier (UDI-DI) starting with 606-400-002 through 606-404-001.
Look for the product sizes and unique identifiers listed in the recall notice to confirm if your item is affected.
The recall states there may be issues with endotoxin testing, but it does not say the product is unsafe. Patients should follow the official recall instructions.
The recall does not specify a remedy, so you should check the product details against the listed sizes and identifiers to determine if it's affected.
Check the product size and unique identifier (UDI-DI) 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-2075-2023 — TEI Biosciences TEI Biosciences Hello, I own a TEI Biosciences that is covered by recall Z-2075-2023 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.
