Collagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions
Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane 6-9 because they may have been packaged with incorrect Instructions for Use.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text identifies the issue as a packaging/labeling error (incorrect Instructions for Use) without reporting any injuries or illnesses, aligning with the 'Moderate' severity criteria for minor labeling errors.
Plain-English summary
Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299. The recall was initiated because the products may have been packaged with an incorrect Instructions for Use.
The affected products are indicated for use in oral surgical procedures as a resorbable material for augmentation around implants, localized ridge augmentation, alveolar ridge reconstruction, filling of bone defects, and guided bone or tissue regeneration. The specific lot number is PDMU19C1, and the UDI is (01)00366975013255(17)210531.
The products were distributed nationwide in the United States, specifically 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. Healthcare professionals and patients should verify the lot number and UDI on their products and contact Collagen Matrix Inc for further instructions.
The recalled product
- Product
- 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 rid
- Manufacturer
- Collagen Matrix Inc
- Hazard
- Affected units
- 192
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI: (01)00366975013255(17)210531
- Lot Number PDMU19C1
Distribution
Part of a larger recall action
This product is one of 6 recalled by Collagen Matrix Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
Same manufacturer · Collagen Matrix Inc
See all →- HighCollagen Dental Wound Dressing Recalled Due to Potential Sterility Compromise
FDA (Devices) · 2022-10-05
- HighRESODURA Matrix Onlay Recalled Due to Unsealed Packaging
FDA (Devices) · 2022-03-02
- HighCollagen Dura Substitute Membrane Recalled for Compromised Sterility
FDA (Devices) · 2022-03-02
- ModerateCollagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions
FDA (Devices) · 2020-02-05
- ModerateCollagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions
FDA (Devices) · 2020-02-05
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02