BEUDAMED
    FDA Recall Terminated

    Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consist of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.

    Recall: Z-3115-2017 · Initiated June 26, 2017

    Recall

    Recall Number
    Z-3115-2017
    Event Number
    77554
    Firm
    Implant Direct Sybron Manufacturing, LLC
    FEI Number
    3001617766
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 26, 2017
    Terminated
    June 16, 2021
    Address
    3050 E Hillcrest Dr, Westlake Village, CA, 91362-3171

    Description

    Spectra-System/Legacy Guided Surgery Handle Kit, Device Listing Number D245883. The Guided Handle Kit (G-HK) allows clinicians to drill through a surgical guide to create an osteotomy for implant placement with the precision and accuracy as designed with treatment planning software. The G-HK consist of 4 guide handles with inserts attached on each end. Each insert has an opening that matches the diameter of our surgical drills. The insert portion of the guide handle fits intimately into the guide sleeve that is embedded into a surgical guide.

    Reason

    The inside diameter of the 2.3mm small drill guide inserts have a smaller diameter than the specifications require.

    Action

    Implant Direct sent an Safety Alert /Advisory Notice letter dated June 26, 2017. Instructions included to review and remove inventory for return to Implant Direct, complete and return the acknowledgement and recall return form, and contact customers and notify the of the recall if product was further distributed. For further questions, please call (888) 649-6425.

    Distribution

    Worldwide Distribution - USA (nationwide) Distribution to the states of : AZ, CA, CO, CT, FL, ID, IL, KS, MI, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA., and to the countries of : Canada, Netherlands, Spain, Great Britain, Germany and Switzerland.

    Quantity

    84 units