Recall Z-2585-2016 ยท MQN External Mandibular Fixator And/Or Distractor
Synthes (USA) Products LLC
TI Single Vector Distractor Proximal Foot/Right; Catalog ID 487.974 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-traumatic defects.
| Date | May 23, 2016 |
| Status | Terminated |
| Reason | DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate. |
| Root cause | Under Investigation by firm |
| Action | The firm, DePuy Synthes, mailed out an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 5/23/2016 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to review your inventory and immediately take the following actions: If you DO have any of the identified devices call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, complete the Verification Section (page 3 of the letter) indicating the number of devices that were found and return the Verification Section (page 3 of the letter) with the product to t |
| Quantity | 274 units |
| Distribution | Worldwide Distribution-US (nationwide) distribution to states of: AZ, CA, CO, DC, FL, IL, MA, MI, NJ, NY, PA, TX, UT, WI, and WV; and countries of: Australia, Canada and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981075 | SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET Synthes (Usa), Jun 22, 1998 |