BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.

    Recall: Z-0014-2014 · Reported October 23, 2013

    Enforcement

    Recall Number
    Z-0014-2014
    Event ID
    65955
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 23, 2013
    Initiation Date
    March 8, 2013
    Classification Date
    October 17, 2013
    Termination Date
    August 12, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417, United States

    Description

    Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.

    Reason

    A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential for bolt back-out or migration by emphasizing the need for supplemental fixation.

    Code Info

    Part Nos.: 04.111.210, 04.111.220, 04.111.230. with Lot Nos.; 2294209 through 7587547.

    Distribution

    Nationwide Distribution, including the states of MI, PA, SC, IA, MA, CA, WI, IL, and KS.

    Quantity

    62