Collagen Matrix Inc recalls GIBSON Healthcare Membrane Extended (30mm x 40mm) due to possible incorrect Instructions for Use. Affected products may cause misuse during oral surgical procedures.
The products may have been packaged with an incorrect Instructions for Use.
Collagen Matrix Inc is recalling GIBSON Healthcare Membrane Extended products for possible incorrect Instructions for Use. This could lead to improper use during oral surgical procedures if users follow the wrong instructions.
The products may have been packaged with incorrect Instructions for Use. This could lead to improper application during oral surgical procedures, potentially causing ineffective treatment or complications.
Oral surgeons and dental professionals who use the GIBSON Healthcare Membrane Extended for surgical procedures may be affected. Those with the specific product model and lot number are most at risk.
Check for the product name 'GIBSON Healthcare Membrane Extended', size 30mm x 40mm, and reference number 5303-342. The lot number EPDMU18H1 is also associated with this recall.
Verify the Instructions for Use with the product's packaging to ensure they match the intended surgical application.
The recall states the products may have incorrect Instructions for Use, so users should check the instructions before use.
Look for the product name 'GIBSON Healthcare Membrane Extended', size 30mm x 40mm, reference number 5303-342, and lot number EPDMU18H1.
Check the Instructions for Use to ensure they are correct before using the product. If unsure, contact Collagen Matrix Inc for assistance.
We’ve drafted a message you can send Collagen Matrix to request your refund or repair — edit it as you like.
Subject: Recall Z-0912-2020 — Collagen Matrix Collagen Matrix Hello, I own a Collagen Matrix that is covered by recall Z-0912-2020 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.
