Lower riskMedical device recall · FDA · Published November 5, 2019
Collagen Matrix Inc: GIBSON Healthcare Membrane Extended recall due to incorrect
Collagen Matrix Inc recalls GIBSON Healthcare Membrane Extended (20mm x 30mm) for possible incorrect instructions. This oral surgical product may cause confusion in use. Consumers should check product details and contact the company for guidance.
“Collagen Matrix Inc: GIBSON Healthcare Membrane Extended recall due to incorrect.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/66563-collagen-matrix-inc-gibson-healthcare-membrane-extended-recall-due-to. Based on FDA recall #Z-0911-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0911-2020%22&limit=1).
The FDA announced on November 5, 2019, that Collagen Matrix Inc. is recalling GIBSON Healthcare Membrane Extended due to potential incorrect Instructions for Use. This Class II recall affects 192 units distributed nationwide.
How to tell if you have it
GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324
UPC 00366975013286
Lot Number EPDMU18H1
The hazard
The products may have been packaged with an incorrect Instructions for Use. The FDA said this error could affect the proper use of the device in oral surgical procedures.
Context
GovInfoNow's records show Collagen Matrix Inc has issued five other recalls since August 16, 2018. Recent similar recalls include a Collagen Dental Wound Dressing recall on August 3, 2022, and a Collagen Matrix RESODURA matrix onlay recall on December 13, 2021. Other recent recalls of similar products include a Medline Convenience Kits Recall (July 10, 2026), a Medline Medical Procedure Kits Recall (March 19, 2026), and an Inter-Med Advance Aluminum Chloride Gel Kit Recall (May 27, 2026).
How to tell if you have this one
Check for the product name 'GIBSON Healthcare Membrane Extended', size 20mm x 30mm, and reference number 5303-324. The product was sold for oral surgical procedures and has a specific lot number (EPDMU18H1).
Brand
Collagen Matrix
Product
GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324
Category
Medical device
FDA recall event · 6 products
All 6 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class II
Status
Terminated
Distribution
US Nationwide distribution in the states of AR, AZ, CA, CO, FL, IL, MA, MD, MI, MN, NC, NJ, NY, OK, PA, SC, TX, UT, VA, and WA.
Recall number
Product, codes & lots
Z-0907-2020
GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.; UDI: (01)00366975013248(17)200630; Lot Number PDMU18F1, PDMU19A1
Z-0908-2020
GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.; UDI: (01)00366975013255(17)200630; Lot Number PDMU18F1
Z-0909-2020
GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.; UDI: (01)00366975013255(17)210531; Lot Number PDMU19C1
Z-0910-2020
GIBSON Healthcare Membrane Extended, 15mm x 20mm, Reference Number 5303-306 - - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.; UDI: (01)00366975013279(17)200630; Lot Number EPDMU18H1
Z-0911-2020
GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.; UDI: (01)00366975013286(17)200630; Lot Number EPDMU18H1
Z-0912-2020
GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - Product Usage: Indicated for use in oral surgical procedures as a resorbable material for use in augmentation around implants placed in immediate extraction sockets, delayed extraction sockets; localized ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.; UDI: (01)00366975013293(17)200630; Lot Number EPDMU18H1
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the product name, size, and reference number on the packaging to confirm if it matches the recalled items.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 20 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of AR, AZ, CA, CO, FL, IL, MA, MD, MI, MN, NC, NJ, NY, OK, PA, SC, TX, UT, VA, and WA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, Arkansas, California, Colorado, Florida, Illinois, Maryland, Massachusetts, Michigan, Minnesota, New Jersey, New York, North Carolina, Oklahoma, Pennsylvania, South Carolina, Texas, Utah, Virginia, Washington.
Recall timeline
FDA terminated this recall 9 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-0911-2020 (November 5, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0911-2020 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.