Recall Z-2148-2014 ยท MQN External Mandibular Fixator And/Or Distractor
Synthes, Inc.
DePuy Synthes Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies)
| Date | Aug 20, 2014 (initiated Apr 16, 2014) |
| Status | Terminated |
| Reason | DePuy Synthes is initiating a recall of certain lots of the Craniomaxillofacial Distraction System (AB Distractor Bodies and BC Distractor Bodies) because they may reverse post-operatively. |
| Root cause | Device Design |
| Action | The firm, DePuy Synthes, sent "Urgent Notice: Medical Device Recall" letters dated April 16, 2014 to affected customers. The letter identified the affected product, reason for recall, potential patient impact, mitigation steps for patients with distractors currently implanted and actions to be taken. Customers were instructed to review inventory, immediately remove the affected lots from stock, complete verification section of the letter and return the affected product. For questions call 610-719-5450 or contact your DePuy Synthes Sales consultant. |
| Quantity | 1499 |
| Distribution | US Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060138 | SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM Synthes (Usa), Jun 2, 2006 |