Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm ADVMNT/0.8mm THK/L and Synthes TI Matrix Pre-Bent Maxillary Plate / 2mm
FDA device recall Z-2272-2015 · posted 2015-07-28 · Terminated
Recall details
- Recalling firm
- Synthes (USA) Products LLC
- Reason for recall
- The affected part and lot numbers of the TI Matrix Pre-Bent Maxillary Plates may potentially have the incorrect laser etch denoting the orientation.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- JEY
- Quantity affected
- 31
- Distribution
- Nationwide Distribution including CA, UT, CO, NJ, WA, VT, KY, WY, CT, NY, MS, and MD.
- Date initiated
- 2015-06-24
- Date posted
- 2015-07-28
- Date terminated
- 2016-08-18
- Location
- West Chester, PA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM (K083388) | Synthes (Usa) | 2009-03-12 |