Collagen Matrix Recalls GIBSON Membrane Due to Incorrect Instructions
Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane Extended because they may have been packaged with incorrect Instructions for Use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, which typically corresponds to a moderate severity score when the issue is a labeling or documentation error (incorrect Instructions for Use) rather than a direct physical defect or contamination.
Plain-English summary
Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane Extended, 20mm x 30mm, Reference Number 5303-324. The recall is due to the possibility that the products were packaged with incorrect Instructions for Use.
The affected product is a resorbable material indicated for use in oral surgical procedures, including augmentation around implants and guided bone regeneration. The specific lot number is EPDMU18H1, with a UDI of (01)00366975013286(17)200630.
The products were distributed nationwide 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 providers and patients should check their inventory and usage records for this specific lot number and reference number.
The recalled product
- Product
- 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…
- 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)00366975013286(17)200630
- Lot Number EPDMU18H1
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
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