Device product
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 and children.
Z-2272-2015
Product summary
- Event
- Event 71595
- Status
- Terminated
- Classification
- Class II
- Quantity
- 31
- Official record key
device-enforcement:Z-2272-2015
Official wording
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.
Code information: Part Numbers: 04.511.381 04.511.382 Lot Numbers: 8672528 8673158 & 8672260
Distribution pattern: Nationwide Distribution including CA, UT, CO, NJ, WA, VT, KY, WY, CT, NY, MS, and MD.
Derived failure modes
-
Unknown
The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have the incorrect laser etch denoting the orientation.