TEI Biosciences recalls PriMatrix Ag Fenestrated Dermal Repair Scaffolds due to potential endotoxin test failures in manufacturing. This is a prescription-only product with specific sizes. No action is required as the hazard is not immediately dangerous.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
TEI Biosciences is recalling certain sizes of PriMatrix Ag Fenestrated Dermal Repair Scaffolds because of possible issues with endotoxin testing during production. This could lead to the product not meeting safety standards, but the recall does not require immediate action.
The product may have endotoxin test results that are out of specification due to issues in the testing process for in-process and finished goods. This could mean the product does not meet safety standards, but it does not pose an immediate risk of injury.
Prescription-only medical devices for skin repair. Patients using these scaffolds for medical treatments may be affected, but the risk is minimal.
Check for the product names 'PriMatrix Ag Fenestrated; Dermal Repair Scaffold' with sizes 10x25 cm, 20x25 cm, 4x4 cm, 6x6 cm, 8x12 cm, or 8x8 cm. The unique identifiers are 607-104-125(10381780113775), 607-104-225(10381780113782), 607-104-440(10381780113560), 607-104-660(10381780113577), 607-104-812(10381780113768), or 607-104-880(10381780113584).
Review the product name and size to confirm if it matches the recalled items listed in the notice.
The recall is due to potential endotoxin test issues, but the product does not pose an immediate risk of injury. No action is required.
No, the recall does not require stopping use. The hazard is not immediately dangerous.
No action is needed as the hazard is low risk and the product does not require immediate disposal or return.
We’ve drafted a message you can send TEI Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2081-2023 — TEI Biosciences TEI Biosciences Hello, I own a TEI Biosciences that is covered by recall Z-2081-2023 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.
