Recall Z-1382-2017 ยท KKY Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
Matrix Surgical Holdings, LLC
OP7543 Design Y Mandible Onlay - Medium - Left and OP7544 Design Y Mandible Onlay - Medium - Right
| Date | Feb 28, 2017 (initiated Jan 25, 2017) |
| Status | Terminated |
| Reason | Mislabeling. The packaging labeled as left mandible contained a right mandible. |
| Root cause | Other |
| Action | Matrix Surgical sent an Urgent Product Recall e-mail dated January 26, 2017, to the foreign consignees. The distributors were instructed to return the product in inventory, and to conduct a sub-recall, if needed. For further questions, please call ( 404) 862-3794. |
| Quantity | 28 |
| Distribution | Worldwide Distribution to the countries of : Brazil, Chile, Colombia, Norway, Saudi Arabia, South Africa, Sweden and Taiwan |
| FDA record | Open on fda.gov |