Recall Z-0904-2013 ยท DZL Screw, Fixation, Intraosseous
Synthes USA HQ, Inc.
Synthes Multi-Vector Distractor, Multi-axial Mandible Distractor (Right), Part Number 487.966. For mandibular bone lengthening.
| Date | Mar 1, 2013 (initiated Jan 11, 2013) |
| Status | Terminated |
| Reason | It was discovered that the sheer pin on the Multi-Vector Distractor may not be made according to product specifications. |
| Root cause | Device Design |
| Action | The firm, Synthes (USA) sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated January 11, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firmat 610-719-5450 for questions regarding this notice. |
| Quantity | 24 |
| Distribution | Nationwide Distribution-including the states of CO, LA, MD, MN, NY, PA, RI, TN, TX and UT. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010690 | SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR Synthes (Usa), May 18, 2001 |