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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:147471

Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short Lot # 5053859 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.

Official recall number

Z-2189-2016

Evidence summary

Product code
HWE
Recall status
Terminated
Event initiated
May 31, 2016
Root cause
Labeling False and Misleading
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2189-2016

Field note

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