BEUDAMED
    FDA Recall Terminated

    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.

    Recall: Z-0473-2014 · Initiated October 9, 2013

    Recall

    Recall Number
    Z-0473-2014
    Event Number
    66582
    Firm
    Synthes USA HQ, Inc.
    FEI Number
    3005180112
    Product Code
    KTT
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    October 9, 2013
    Posted
    December 10, 2013
    Terminated
    December 18, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    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.

    Reason

    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.

    Action

    Synthes sent an Urgent Field Safety Notification/Medical Device Labeling Correction letter dated October 9, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to exchange the old surgical technique guide version J5606-C with the new version J5606-D provided with this notification. Review the revised surgical technique guide (Pages 25 & 26). Forward this Field Safety Notification to anyone in their facility that need to be informed. If the surgical technique guide has been forwarded to another facility, contact that facility. Maintain awareness of this notice until all surgical technique guides have been exchanged. Maintain a copy of this notice. Customers with questions were instructed to contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.

    Distribution

    Worldwide Distribution - USA (nationwide) Canada and Mexico

    Quantity

    2912