GIBSON Healthcare Membrane Extended Recalled for Incorrect Instructions for Use
Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane Extended 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 hazard involves incorrect labeling (Instructions for Use) without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342. The product is a resorbable material indicated for use in oral surgical procedures, including augmentation around implants and guided bone regeneration.
The recall was initiated because the products may have been packaged with an incorrect Instructions for Use. The affected units are identified by Lot Number EPDMU18H1 and UDI (01)00366975013293(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 should check their inventory for this specific lot number and discontinue use if found.
The recalled product
- Product
- 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; localize
- 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)00366975013293(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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