GIBSON Healthcare Membrane Recalled for Incorrect Instructions for Use
Collagen Matrix Inc is recalling GIBSON Healthcare Membrane 6-9 units 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 situation where use of the product may cause temporary or medically reversible adverse health consequences. The specific hazard is a labeling error (incorrect Instructions for Use) rather than a physical defect or contamination, 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, 20mm x 30mm, Reference Number 5303-235. The product is 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 was initiated because the products may have been packaged with an incorrect Instructions for Use. The affected units are identified by UDI (01)00366975013255(17)200630 and Lot Number PDMU18F1.
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 consumers should check their inventory for the specific lot number and discontinue use of the affected units.
The recalled product
- Product
- 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 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)200630
- Lot Number PDMU18F1
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.
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