BEUDAMED
    FDA Recall 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 · Initiated April 16, 2015

    Recall

    Recall Number
    Z-1605-2015
    Event Number
    71125
    Firm
    BioHorizons Implant Systems Inc
    FEI Number
    1000592496
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 16, 2015
    Posted
    May 12, 2015
    Terminated
    August 7, 2015
    Address
    2300 Riverchase Ctr, Hoover, AL, 35244-2808

    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.

    Action

    BioHorizons sent an Urgent Medical Device Field Correction letter on 04/16/2015 to affected customers. Non-responding customers will be notified after 30 days. The letter identified the affected product, problem and actions to be taken. For questions contact Customer Care Department at 888-246-8338.

    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