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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:183672

Bien-Air Surgery REF 1600407-001 SN **** FOOTCTRL OSSEODOC - Product Usage: intended to convert electrical energy to mechanically drive handpieces and microsaws used to cut and shape bones.

Official recall number

Z-0176-2021

Evidence summary

Product code
ERL
Recall status
Open, Classified
Event initiated
September 11, 2020
Root cause
Process control
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0176-2021

Field note

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