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.
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, which typically indicates a temporary or medically reversible adverse health consequence. The hazard is a labeling error (incorrect Instructions for Use) without reported injuries or illnesses, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
Collagen Matrix Inc is recalling 192 units of GIBSON Healthcare Membrane Extended, 15mm x 20mm (Reference Number 5303-306). The recall is due to the possibility that the products were packaged with incorrect Instructions for Use.
The affected products are indicated for use in oral surgical procedures as a resorbable material for various dental applications, including augmentation around implants and guided bone regeneration. The recall covers units 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.
The specific lot number is EPDMU18H1. Healthcare professionals and consumers should check their inventory for this specific product and lot number. If the product is found, it should be removed from use and returned to the distributor or manufacturer.
The recalled product
- Product
- 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; locali
- 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)00366975013279(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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