TEI Biosciences recalls PriMatrix Dermal Repair Scaffolds due to potential endotoxin test failures in manufacturing. Affected sizes include 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).
Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.
TEI Biosciences is recalling PriMatrix Dermal Repair Scaffolds that may have endotoxin test results outside specifications. This could pose a risk of infection or other health issues if used improperly.
The scaffolds may have endotoxin test results that don't meet specifications. Endotoxins are bacterial components that can cause infections if introduced into the body during medical procedures.
Patients using these medical scaffolds for dermal repair are most at risk. The recall applies to specific sizes sold under the brand name PriMatrix.
Check for the product names: PriMatrix Fenestrated Dermal Repair Scaffold. Affected sizes include 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1). The unique identifiers are 607-004-440 (10381780113379), 607-004-660 (10381780113386), 607-004-880 (10381780113393), 607-005-014 (10381780357414), 607-005-018 (10381780357421), 607-005-125 (10381780113409), and 607-005-220 (10381780357407).
Look for the product names and sizes listed in the recall notice to confirm if your item is affected.
TEI Biosciences is recalling PriMatrix Dermal Repair Scaffolds that may have endotoxin test results outside specifications.
Affected sizes include 4x4 cm, 6x6 cm, 8x8 cm, 14mm Disc, 18mm Disc, 2x2 cm, and 10x25 cm (Meshed 2:1).
Check the product name and size against the list provided in the recall notice, including the unique identifiers.
We’ve drafted a message you can send TEI Biosciences to request your refund or repair — edit it as you like.
Subject: Recall Z-2078-2023 — TEI Biosciences TEI Biosciences Hello, I own a TEI Biosciences that is covered by recall Z-2078-2023 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.
