Z-0908-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 5, 2020
- Initiation Date
- November 5, 2019
- Termination Date
- August 3, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 192 total
Product Description
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.
Reason for Recall
The products may have been packaged with an incorrect Instructions for Use.
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.
Code Information
UDI: (01)00366975013255(17)200630; Lot Number PDMU18F1