FDA recall Z-0909-2020

Collagen Matrix Inc · Class II · device

Product

GIBSON Healthcare Membrane 6-9, 30mm x 40mm, Reference Number 5303-299 - 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.

Reason for recall

The products may have been packaged with an incorrect Instructions for Use.

Distribution

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.

Key facts

Status
Terminated
Initiation date
2019-11-05
Report date
2020-02-05
Termination date
2020-08-03
Voluntary/Mandated
Voluntary: Firm initiated
Location
Oakland, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0909-2020