Recall Z-1745-2013 ยท DZL Screw, Fixation, Intraosseous
Synthes USA HQ, Inc.
Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distractor which cis used for mandibular bone lengthening, including conditions such as congenital mandibular deficiencies or post-traumatic defects. The Multi Vector Distractor can be utilized to perform bone transport procedures as an alternative to bone grafts and free flaps.
| Date | Jul 17, 2013 (initiated May 31, 2013) |
| Status | Terminated |
| Reason | Synthes is initiating a voluntary Medical Device removal for specified part numbers and lot numbers of the Mutis Vector Distractor Pin Holding clamp, limited bone stock. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp, however there |
| Root cause | Device Design |
| Action | Synthes sent a Urgent Notice: Medical Device Removal letter dated May 31, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customers. The firm received complaints that the clamp and nut construct would not engage the distractor arm threads and subsequently bind. It is not likely that a serious adverse event will result due to a nonconforming clamp, however, there is a remote potential that additional intervention would be required due to a non-functioning clamp. Synthes requested the product to be removed from inventory |
| Quantity | 121 |
| Distribution | US Nationwide Distribution including the states of MA, TX, MN, SC, UT, VA, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010690 | SYNTHES TITANIUM MULTI-VECTOR DISTRACTOR Synthes (Usa), May 18, 2001 |