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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:122651

Synthes TomoFix Plates The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.

Official recall number

Z-0473-2014

Evidence summary

Product code
KTT
Recall status
Terminated
Event initiated
October 09, 2013
Root cause
Labeling False and Misleading
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0473-2014

Field note

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