Collagen Matrix recalls DuraMatrix-Onlay collagen membrane (4x5 inches) due to unsealed outer pouch risking patient infection. Affected units have specific lot/expiry dates. Contact for return instructions.
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 collagen membrane product because its outer packaging isn't sealed properly. This could lead to infections requiring revision surgery if used in medical procedures.
The outer pouch isn't sealed, which compromises the product's sterility. This means the membrane could become contaminated during use, potentially causing infections that might require additional surgery.
Medical professionals using this membrane for surgical procedures are most at risk. Patients receiving the product during surgery could face infection complications.
Check for the product name 'DuraMatrix-Onlay Collagen Dura Substitute Membrane' with size 4 inches x 5 inches (10.0cm x 12.5cm). Look for lot number 2107292022 and expiration date 7/31/2024 on the packaging.
Identify the product by its size (4x5 inches), 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, which could lead to infection risks. Do not use the product until the recall remedy is followed.
Check for the product name 'DuraMatrix-Onlay Collagen Dura Substitute Membrane' with size 4 inches x 5 inches (10.0cm x 12.5cm), lot number 2107292022, and expiration date 7/31/2024.
The recall remedy is not specified in the record, so contact Collagen Matrix directly for instructions.
We’ve drafted a message you can send Collagen Matrix to request your refund or repair — edit it as you like.
Subject: Recall Z-0668-2022 — Collagen Matrix Collagen Matrix Hello, I own a Collagen Matrix that is covered by recall Z-0668-2022 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.