Recall Z-0908-2020 ยท NPL Barrier, Animal Source, Intraoral
Collagen Matrix Inc
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;
| Date | Nov 5, 2019 |
| Status | Terminated |
| Reason | The products may have been packaged with an incorrect Instructions for Use. |
| Root cause | Labeling mix-ups |
| Action | 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 rec |
| Quantity | 192 total |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100156 | COLLAGEN DENTAL MEMBRANE V Collagen Matrix, Inc., Aug 11, 2010 |