Collagen Matrix recalls GIBSON Healthcare Membrane 6-9 (30mm x 40mm) due to potential incorrect Instructions for Use. This affects oral surgical procedures.
The products may have been packaged with an incorrect Instructions for Use.
Collagen Matrix is recalling GIBSON Healthcare Membrane products used in oral surgery because they might have been packaged with incorrect instructions. This could lead to improper use during dental procedures.
The products may have been packaged with incorrect Instructions for Use, which could lead to improper application during oral surgical procedures. This might cause ineffective treatment or complications if the user does not follow the correct steps.
Oral surgery patients and dental professionals who use the GIBSON Healthcare Membrane 6-9 (30mm x 40mm) for procedures like implant placement or bone augmentation. Those most at risk are users who follow the instructions without verifying the packaging.
Check for the product name 'GIBSON Healthcare Membrane 6-9', size 30mm x 40mm, and reference number 5303-299. The product is intended for use in oral surgical procedures.
Verify the Instructions for Use are correct before using the product in oral surgical procedures.
The products may have been packaged with incorrect Instructions for Use, which could lead to improper application during oral surgical procedures.
The official recall notice does not specify a remedy or action steps beyond checking the Instructions for Use.
The recall states the products may have incorrect Instructions for Use, but does not mention a risk of serious injury.
We’ve drafted a message you can send Collagen Matrix to request your refund or repair — edit it as you like.
Subject: Recall Z-0909-2020 — Collagen Matrix Collagen Matrix Hello, I own a Collagen Matrix that is covered by recall Z-0909-2020 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.
