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Collagen Matrix Inc recalls GIBSON Healthcare Membrane 6-9, 20mm x 30mm, Reference Number 5303-235 - Product Usage: Indicated for use in oral surgic
Recalled February 5, 2020 · FDA recall Z-0908-2020 · Collagen Matrix
Hazard
The products may have been packaged with an incorrect Instructions for Use. · FDA Class II
Units
192 total
Sold at
US Nationwide distribution 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.
Description
The products may have been packaged with an incorrect Instructions for Use.
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 ridge augmentation for later implantation; alveolar ridge reconstruction for prosthetic treatment; filling of bone defects; guided bone regeneration in dehiscence defects and guided tissue regeneration procedures in periodontal defects.
Manufacturer(s)
Collagen Matrix Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →