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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:184018

SYNMESH 12MM DIA 88MM HEIGHT (TI) Product Number: 495.357 - Product Usage: is a vertebral body replacement device for the cervical, thoracic and lumbar spine. Titanium implants in various footprints and heights enable the surgeon to choose the configuration that is best suited to the patient s individual pathology and anatomy. The mesh may also be trimmed for a custom fit. The implants can be inserted anteriorly, laterally or anterolaterally.

Official recall number

Z-0404-2021

Evidence summary

Product code
MQP
Recall status
Terminated
Event initiated
September 21, 2020
Root cause
Unknown/Undetermined by firm
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0404-2021

Field note

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