Recall Z-1110-2017 ยท NPL Barrier, Animal Source, Intraoral
Biom'up
RENOVIX Guided Healing Collagen Membrane Intended for use in oral surgical procedures.
| Date | Jan 27, 2017 (initiated Dec 2, 2016) |
| Status | Terminated |
| Reason | Lack of sterility assurance |
| Root cause | Nonconforming Material/Component |
| Action | An Urgent Medical Device Recall letter was mailed to affected customer on 12/02/2016 to inform them of the recall. The reason and actions to be taken were explained in the letter. Customer was asked to examine their inventory and contact Biom'Up to arrange for return of product. |
| Quantity | 1,682 units |
| Distribution | Distributed to a sole distributor in NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103087 | COVAMAX RESORBABLE COLLAGEN MEMBRANE Biom'Up Sas, Aug 26, 2011 |