GIBSON Healthcare Membrane Extended, 30mm x 40mm, Reference Number 5303-342 - 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.
- Company
- Collagen Matrix Inc
- Recall Initiated
- November 5, 2019
- Terminated
- August 3, 2020
- Recall Number
- Z-0912-2020
- Quantity
- 192 total
- Firm Location
- Oakland, NJ
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.
Lot / Code Info
UDI: (01)00366975013293(17)200630; Lot Number EPDMU18H1
Root Cause
Labeling mix-ups
Action Taken
Urgent Medical Device Recall Notice letters dated 11/5/19 were sent to customers. IMMEDIATE ACTIONS TO BE TAKEN BY THE CUSTOMER 1. Check your inventory to determine if any of the affected product remains in your stock and segregate all affected units from your inventory for return. 2. Complete the attached Certificate of Acknowledgement form with the appropriate information and return within 5 days of receiving this notice. The completed form can be emailed to recalls@collagenmatrix.com or returned by mail to: Product Recall Collagen Matrix, Inc. 15 Thornton Road Oakland, NJ 07436 Upon receipt of the completed form, Benco Dental will ship replacement product and a prepaid return shipping label will be provided with further instructions for returning product that remains in your possession. OTHER INFORMATION If you have any questions after reviewing this notice, please call 1-800-462-3626 between 7:00am and 8:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a prompt to leave a voicemail.