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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:181365

Vital MIS Spinal Fixation system implants CANN POLY EXT TAB 5.5X45MM, Item Number 810M5545 - Product Usage: are non-cervical spinal fixation devices intended for posterior pedicle screw fixation, posterior hook fixation, or anterolateral fixation. Pedicle screw fixation is indicated for skeletally mature patients and for adolescence patients.

Official recall number

Z-2216-2020

Evidence summary

Product code
NKB
Recall status
Terminated
Event initiated
May 05, 2020
Root cause
Under Investigation by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-2216-2020

Field note

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