Recall Z-1223-2019 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Matrix Surgical Holdings, LLC
OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in block, sheet, and anatomical shapes are intended for nonweight bearing applications of craniofacial reconstruction/cosmetic surgery and repair of craniofacial trauma. OmniPore Surgical Implants are also intended for the augmentation or restoration of contour in the craniomaxillofacial skeleton.
| Date | Jan 30, 2019 |
| Status | Terminated |
| Reason | Product mislabeling. |
| Root cause | Employee error |
| Action | Distributor are being instructed to return all affect product in their inventory to Matrix Surgical. Additionally, they are being instructed to contact the user they have distributed affect product to and attempt to retrieve product or confirm use. If product is retuned by the User to the Distributor, then the Distribution is to return the product to the Matrix Surgical. NOTE: All product was distributed outside of the United States where all User distribution is managed by Distributors. The product will be retuning utilizing a Returns Goods Authorization per our internal procedures and re |
| Quantity | 46 |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of Florida and Massachusetts and countries of Argentina, Chile, Colombia, Iran, Mexico, Norway, Taiwan, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123908 | OMNIPORE SURGICAL IMPLANTS AND ACCESSORIES Matrix Surgical USA, Jul 31, 2013 |