Recall Z-1781-2014 ยท HTZ Instrument, Cutting, Orthopedic
Synthes, Inc.
Synthes Matrix Mandible Short Cut Plate Cutter Synthes Matrix Mandible Short Cut Plate Cutter is intended for oral, maxillofacial surgery.
| Date | Jun 11, 2014 (initiated Apr 22, 2014) |
| Status | Terminated |
| Reason | It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the affected lot. |
| Root cause | Device Design |
| Action | Synthes Inc. sent an Urgent Medical Device Recall Notice dated April 22, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. If you DO have any of the identified devices, please take the following steps: Contact DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number . Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found. Please include your name, title, telepho |
| Quantity | 14 |
| Distribution | US Distribution including the states of CA, CT, FL, GA, NY, SD and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.