Device recall
Z-2272-2015: Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes…
FDA device recall · Class II · Synthes (USA) Products LLC
Key facts
| Recall number (Z-number) | Z-2272-2015 |
|---|---|
| Recall event | 71595 |
| 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… |
| Product code | JEY |
| Recalling firm | Synthes (USA) Products LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 18, 2016 |
| 510(k) numbers | K083388 |
| FEI number | 3008812560 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database