FDA-Device2013-12-18Class II
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.
Synthes USA HQ, Inc.
Hazard
A labeling correction was initiated related to the Surgical Technique Guide J5606-C "TomoFix Osteotomy System" due to the potential for a surgical delay if the surgeon inserts the superior screws at a lesser angle (4 or 6 degrees) and is not aware that those angles are not present.
Sold states
Worldwide Distribution - USA (nationwide) Canada and Mexico
Affected count
2912
Manufactured in
1302 Wrights Ln E, West Chester, PA, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0473-2014Don't want to check this manually?
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