FDAMay 23, 2016device

TI Single Vector Distractor Body with Right Foot/30mm; Catalog ID 487.964 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...

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

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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