BEUDAMED
    FDA Enforcement Class II Terminated

    Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform

    Recall: Z-0539-2018 · Reported February 14, 2018

    Enforcement

    Recall Number
    Z-0539-2018
    Event ID
    78917
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Implant Direct Sybron Manufacturing, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 14, 2018
    Initiation Date
    January 23, 2018
    Classification Date
    February 6, 2018
    Termination Date
    August 9, 2018
    Address
    3050 E Hillcrest Dr, N/A, Westlake Village, CA, 91362-3171, United States

    Description

    Implant Direct, INTERACTIVE HEALING COLLAR, PART NUMBER 6530-15, 5.0mmL: 3.0mmD Platform

    Reason

    InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.

    Code Info

    Lot Number 104203

    Distribution

    CO, SC, IA, NJ, FL, CA, VA, ID, Netherlands

    Quantity

    55 units