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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:115737

Synthes Dens Instrument Set (Dens Graphic Case), Part Number 687.030 (also known as the Anterior Column Retractor Set) The Synthes Dens instrument Set has been designed to facilitate internal fixation of the odontoid process for the reduction of Type II and shallow Type III fractures, as proposed by Anderson and d'Alonzo.

Official recall number

Z-1016-2013

Evidence summary

Product code
HWC
Recall status
Terminated
Event initiated
January 11, 2013
Root cause
No Marketing Application
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-1016-2013

Field note

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