TEI Biosciences recalls PriMatrix Ag Meshed Dermal Repair Scaffolds due to potential endotoxin test failures in manufacturing. Affected units have specific sizes and UDI-DI numbers. Consumers should contact TEI for details.
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
TEI Biosciences is recalling PriMatrix Ag Meshed Dermal Repair Scaffolds because endotoxin testing may have been out of specification. This could lead to unsafe levels of endotoxins in the product, though the recall does not mention specific injury risks.
The recall states that endotoxin test results may be out of specification due to issues in the testing process for in-process and finished goods. Endotoxins are bacterial components that can cause adverse reactions if present in high levels, but the recall does not specify serious injury risks.
Medical professionals using the PriMatrix Ag Meshed Dermal Repair Scaffolds for prescription treatments are likely affected. Patients using these products under medical supervision are at minimal risk if the product is properly handled.
Check for the product names 'PriMatrix Ag Meshed' or 'Dermal Repair Scaffold' with sizes listed in the recall. Affected units have specific UDI-DI numbers: 607-105-112 (10381780177685), 607-105-125 (10381780113591), etc.
Reach out to TEI Biosciences for specific guidance on affected units and next steps.
The recall indicates possible endotoxin test issues, but it does not state that the product is unsafe for use. Consumers should contact TEI for details.
The recall mentions possible out of specification endotoxin test results due to issues with in-process and finished goods testing.
Check for the product names 'PriMatrix Ag Meshed' or 'Dermal Repair Scaffold' with the listed sizes and UDI-DI numbers provided in the recall.
We’ve drafted a message you can send TEI Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2082-2023 — TEI Biosciences TEI Biosciences Hello, I own a TEI Biosciences that is covered by recall Z-2082-2023 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.
