BEUDAMED
    FDA Enforcement Class II Terminated

    Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement

    Recall: Z-1605-2015 · Reported May 20, 2015

    Enforcement

    Recall Number
    Z-1605-2015
    Event ID
    71125
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BioHorizons Implant Systems Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 20, 2015
    Initiation Date
    April 16, 2015
    Classification Date
    May 12, 2015
    Termination Date
    August 7, 2015
    Address
    2300 Riverchase Ctr, N/A, Hoover, AL, 35244-2808, United States

    Description

    Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement

    Reason

    BioHorizons Tapered HD Upgrade set was packaged with an incorrect drill component manufactured of stainless steel in place of the correct component manufactured from titanium.

    Code Info

    Lot Number 1501968

    Distribution

    US Nationwide in the states of: AL, FL, MS, VA, LA, CA, NC, TX, TN, OH, OK, VT, WA, MD, NY, SD, and SC.

    Quantity

    48 units