Device product
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.
Z-1745-2013
Product summary
- Event
- Event 65561
- Status
- Terminated
- Classification
- Class II
- Quantity
- 121
- Official record key
device-enforcement:Z-1745-2013
Official wording
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
Code information: Titanium Multi Vector Distractor Pin Holding Clamp, body, limited bone stock Part # 487.941 with lot numbers: 3769720, 3779569, 3788731, 3794434, 7806093, 7823463 and Titanium Multi Vector Distractor Pin Holding Clamp, ramus, limited bone stock Part # 487.942 with lot numbers: 3769706, 3779571, 3788741, 7806096, 7823464.
Distribution pattern: US Nationwide Distribution including the states of MA, TX, MN, SC, UT, VA, and NY.
Derived failure modes
-
Unknown
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