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Synthes USA HQ, Inc. recalls Multi Vector Distractor Pin Holding Clamp, limited bone stock The holding clamp is part of the Multi Vector Distracto
Recalled July 24, 2013 · FDA recall Z-1745-2013 · Synthes USA HQ
Hazard
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 · FDA Class II
Units
121
Sold at
US Nationwide Distribution including the states of MA, TX, MN, SC, UT, VA, and NY.
Description
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
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.
Manufacturer(s)
Synthes USA HQ, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →