BEUDAMED
    FDA Enforcement Class II Terminated

    MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.

    Recall: Z-0062-2015 · Reported October 15, 2014

    Enforcement

    Recall Number
    Z-0062-2015
    Event ID
    69294
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthohelix Surgical Designs Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 15, 2014
    Initiation Date
    September 19, 2014
    Classification Date
    October 9, 2014
    Termination Date
    October 31, 2016
    Address
    1065 Medina Rd Ste 500, Medina, OH, 44256-5376, United States

    Description

    MaxLock Extreme Mod-Foot Concave Reamer; Individually packaged in a 3 x 4 bag and heat sealed with label on the outside. Used during procedures to clear away bone and cartilage within the desired implant area.

    Reason

    Incorrect sizing was being laser etched on the MaxLock Extreme Mod-Foot Concave Reamer

    Code Info

    Part Number: MFT-074-CC-24; Lot: 3164011

    Distribution

    USA Distribution -- in the states of WI, NM, TX, WA, MO, OH, UT, TN, MI, VA, NC, VA, and PA.

    Quantity

    38