FDAMay 23, 2016device
TI Single Vector Distractor Proximal Foot/Left; Catalog ID 487.975 The Titanium Single Vector Distractor and Proximal Foot Plates are intended for mandibular bone lengthening where gradual bone distraction is required, including conditions such as congenital mandibular deficiencies or post-trauma...
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
DePuy Synthes is voluntarily initiating a recall due to a possibility the fastener on the Titanium Single Vector Distractor Body may become prematurely separated from the Proximal Foot Plate.
What to do
FDA enforcement status: Terminated
Brands named
synthes usa productssynthessynthes usa
Recall history
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