BEUDAMED
    FDA Enforcement Class II 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 · Reported September 20, 2017

    Enforcement

    Recall Number
    Z-3115-2017
    Event ID
    77554
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Implant Direct Sybron Manufacturing, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 20, 2017
    Initiation Date
    June 26, 2017
    Classification Date
    September 11, 2017
    Termination Date
    June 16, 2021
    Address
    3050 E Hillcrest Dr, N/A, Westlake Village, CA, 91362-3171, United States

    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.

    Code Info

    Lot 65249, Sequence Number HE G-HKRev01, Device Listing Number D245883.

    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