TEI Biosciences recalls SurgiMend 2.0 collagen matrix products due to possible endotoxin test failures in manufacturing. These are prescription-only surgical materials 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 2.0 collagen matrix products for soft tissue reconstruction because of possible endotoxin test failures during manufacturing. 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 infections if present in medical products. However, the hazard is not described as causing immediate injury or serious harm in normal use.
Prescription-only surgical patients using SurgiMend 2.0 collagen matrix products for soft tissue reconstruction. Healthcare providers and patients who received these products from the manufacturer are most at risk.
Check for the product names 'SurgiMend 2.0; Collagen Matrix for Soft Tissue Reconstruction' with sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, and other listed sizes. The unique identifiers (UDI-DI) include 606-200-002 through 606-204-100.
Verify the product size and unique identifiers (UDI-DI) listed in the recall notice to confirm if your item is affected.
The recall states possible endotoxin test failures but does not indicate that the product is unsafe for use. Patients should follow the manufacturer's instructions.
Check the product size and unique identifiers (UDI-DI) listed in the recall notice: sizes 5x6 cm, 6x12 cm, 10x15 cm, 16x20 cm, and UDI-DI numbers 606-200-002 through 606-204-100.
The recall does not specify a remedy, so no action is required beyond checking if your product matches the listed details.
We’ve drafted a message you can send TEI Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2072-2023 — TEI Biosciences TEI Biosciences Hello, I own a TEI Biosciences that is covered by recall Z-2072-2023 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.
