TEI Biosciences recalls Revize collagen matrix products due to potential endotoxin test failures. These Rx-only medical devices may not meet safety standards 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 specific sizes of Revize collagen matrix products for soft tissue reconstruction. The recall is due to possible endotoxin test results that may not meet specifications, which could affect medical safety.
Endotoxins are harmful substances found in the cell walls of bacteria. If the endotoxin test results are out of specification, there could be a risk of adverse reactions in patients undergoing medical procedures.
Medical professionals who use these Rx-only collagen matrix products for soft tissue reconstruction are likely affected. Patients receiving these products would be at risk if the endotoxin test results are not properly controlled.
Check for the product names 'Revize; Collagen Matrix for Soft Tissue Reconstruction' with sizes 10x10 cm, 4x12 cm, or 4x16 cm. The unique identifiers are 611-001-001 (10381780357292), 611-001-002 (10381780357278), or 611-001-003 (10381780357285).
Look for the product names and sizes listed in the recall notice to confirm if your item is affected.
The recall is due to possible out of specification endotoxin test results, which could affect medical safety.
The recall notice does not specify a remedy, so check with the manufacturer for further instructions.
Yes, sizes 10x10 cm, 4x12 cm, and 4x16 cm 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-2083-2023 — TEI Biosciences TEI Biosciences Hello, I own a TEI Biosciences that is covered by recall Z-2083-2023 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.
