Device product
GIBSON Healthcare Membrane 6-9, 15mm x 20mm, Reference Number 5303-226 - 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.
Z-0907-2020
Product summary
- Event
- Event 84334
- Status
- Terminated
- Classification
- Class II
- Quantity
- 192 total
- Official record key
device-enforcement:Z-0907-2020
Official wording
Reason: The products may have been packaged with an incorrect Instructions for Use.
Code information: UDI: (01)00366975013248(17)200630; Lot Number PDMU18F1, PDMU19A1
Distribution pattern: 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.
Derived failure modes
-
Unknown
The products may have been packaged with an incorrect Instructions for Use.