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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:160940

ROSA Spine 1.0.2 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by surgeons.

Official recall number

Z-0639-2018

Evidence summary

Product code
OLO
Recall status
Terminated
Event initiated
May 01, 2017
Root cause
Software design
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0639-2018

Field note

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