Recall Z-1726-2013 ยท MQN External Mandibular Fixator And/Or Distractor
Synthes USA HQ, Inc.
Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.
| Date | Jul 12, 2013 (initiated Jun 12, 2013) |
| Status | Terminated |
| Reason | The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. There have been instances reported within the impacted lots in which the slot in the barrel of the BC distractor was rotated such that it was not possible to attach the B-type and C-type foot plates. |
| Root cause | Nonconforming Material/Component |
| Action | SYNTHES sent an Urgent Notice: Medical Device Recall letter dated June 12, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to examine their inventory for affected product, remove it from use, and return it to Synthes. If they have affected product they were instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. Complete the Verification Section at the end of the letter and indicate the number of devices found and note the Return Authorization Number and retu |
| Quantity | 10 |
| Distribution | Nationwide Distribution including PA, CT, DE, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060138 | SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM Synthes (Usa), Jun 2, 2006 |