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.
Recall
- Recall Number
- Z-1745-2013
- Event Number
- 65561
- Firm
- Synthes USA HQ, Inc.
- FEI Number
- 3005180112
- Product Code
- DZL
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- May 31, 2013
- Posted
- July 17, 2013
- Terminated
- August 31, 2015
- Address
- 1302 Wrights Ln E, West Chester, PA, 19380-3417
Description
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.
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
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 and returned to Synthes by calling 1-800-479-6329 to obtain a Return Authorization Number. Direct Accounts were asked to complete and return the Verification Section at the end of the letter indicating the quantity of affected product was found. Negative responses were also requested. If you have any questions please call (610) 719-5450.
US Nationwide Distribution including the states of MA, TX, MN, SC, UT, VA, and NY.
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