Recall Z-2272-2015 ยท JEY Plate, Bone
Synthes (USA) Products LLC
Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/R. The Synthes Matrix ORTHOGNATHIC Fixation System is intended for use in selective trauma of the midface and craniofacial skeleton; craniofacial surgery; reconstructive procedures; and selective orthognathic surgery of the maxilla, mandible and chin in adults
| Date | Jul 28, 2015 (initiated Jun 24, 2015) |
| Status | Terminated |
| Reason | The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have the incorrect laser etch denoting the orientation. |
| Root cause | Process control |
| Action | DePuy Synthes sent an Urgent Notice Medical Device Recall letter dated June 24, 2015, to all affected customers. Customers were asked to check their inventory and return affected devices with the completed response form. Customers with questions were instructed to call 610-719-5450 or contact their DePuy Synthes Sales Consultant. |
| Quantity | 31 |
| Distribution | Nationwide Distribution including CA, UT, CO, NJ, WA, VT, KY, WY, CT, NY, MS, and MD. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083388 | SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM Synthes (Usa), Mar 12, 2009 |