Collagen Matrix recalls GIBSON Healthcare Membrane 6-9 (15mm x 20mm) due to possible incorrect Instructions for Use. This affects oral surgical products sold with specific lot numbers.
The products may have been packaged with an incorrect Instructions for Use.
Collagen Matrix is recalling GIBSON Healthcare Membrane products for possible incorrect Instructions for Use. This could lead to improper use during oral surgical procedures, though the risk is not described as serious.
The products may have been packaged with incorrect Instructions for Use. This could lead to improper application during oral surgical procedures, potentially causing complications if the product is used incorrectly.
Oral surgery patients using the GIBSON Healthcare Membrane 6-9 (15mm x 20mm) with lot numbers PDMU18F1 or PDMU19A1 are affected. Patients using the product for oral surgical procedures are most at risk.
Check for the product name 'GIBSON Healthcare Membrane 6-9', size 15mm x 20mm, and lot numbers PDMU18F1 or PDMU19A1. The product is intended for use in oral surgical procedures.
Look for lot numbers PDMU18F1 or PDMU19A1 on the packaging.
The recall states the products may have incorrect Instructions for Use, but the product itself is not unsafe. Proper use as intended is recommended.
The recall does not specify a remedy, so no action is required unless you find incorrect instructions.
Check for the product name 'GIBSON Healthcare Membrane 6-9', size 15mm x 20mm, and lot numbers PDMU18F1 or PDMU19A1.
We’ve drafted a message you can send Collagen Matrix to request your refund or repair — edit it as you like.
Subject: Recall Z-0907-2020 — Collagen Matrix Collagen Matrix Hello, I own a Collagen Matrix that is covered by recall Z-0907-2020 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.
