Collagen Matrix recalls RESODURA matrix onlay 10.0cm x 12.5cm due to unsealed outer pouch risking infection during surgery. Affected units have specific lot numbers and expiration dates.
Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery
Collagen Matrix is recalling a specific type of surgical mesh product because its outer packaging isn't sealed properly. This could lead to infections during surgery, requiring additional procedures.
The outer pouch isn't sealed properly, which can compromise sterility. This means the product might not be clean enough for surgery, increasing the risk of infection that could require revision surgery.
Surgical patients who received the RESODURA matrix onlay 10.0 cm x 12.5 cm with the specified lot number and expiration date are affected. Surgeons and hospitals using this product are most at risk.
Check for the product name 'RESODURA matrix onlay 10.0 cm x 12.5 cm' with lot number 2107292022 and expiration date 7/31/2024. The product was sold with a specific UDI code.
Look for the lot number 2107292022 and expiration date 7/31/2024 on the packaging.
The product is not safe for use as the outer pouch isn't sealed properly, which could lead to infection during surgery.
The official recall notice does not specify a remedy, so contact Collagen Matrix directly for guidance.
Check for the product name 'RESODURA matrix onlay 10.0 cm x 12.5 cm' with lot number 2107292022 and expiration date 7/31/2024.
We’ve drafted a message you can send Collagen Matrix to request your refund or repair — edit it as you like.
Subject: Recall Z-0669-2022 — Collagen Matrix Collagen Matrix Hello, I own a Collagen Matrix that is covered by recall Z-0669-2022 from Collagen Matrix. 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.
