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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:156568

PALLAS M/MAXIMIS 70mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation System. Valorem Surgical, Chicago, IL. Product labeled as Pallas M Spinal Fixation System through 2015. Intended for posterior pedicle screw fixation of the non-cervical spine.

Official recall number

Z-2945-2017

Evidence summary

Product code
MNI
Recall status
Terminated
Event initiated
June 21, 2017
Root cause
Device Design
Source snapshot
d51b4b87fdeb9ccf809d8b814d67f3a0fa43ac67bead6c171fe27284699c3275
Product
Z-2945-2017

Field note

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