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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:147493

TI Single Vector Distractor Body with Left Foot/20mm; Catalog ID 487.963 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-traumatic defects.

Official recall number

Z-2582-2016

Evidence summary

Product code
MQN
Recall status
Terminated
Event initiated
May 23, 2016
Root cause
Under Investigation by firm
Source snapshot
d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product
Z-2582-2016

Field note

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