BEUDAMED
    FDA Recall Terminated

    Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112

    Recall: Z-1061-2019 · Initiated February 22, 2019

    Recall

    Recall Number
    Z-1061-2019
    Event Number
    82374
    Firm
    Keystone Dental Inc
    FEI Number
    3005990499
    Product Code
    DZE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 22, 2019
    Terminated
    June 19, 2020
    Address
    154 Middlesex Tpke, Burlington, MA, 01803-4403

    Description

    Paltop Premium Surgical Kit-containing the 1.25mm Hex Driver For surgical and restorative applications prosthetic devices, such as artificial teeth Part Number: 60-70112

    Reason

    Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature

    Action

    Keystone Dental initiated recall by phone to each one of the impacted customers. The phone call was then followed by a Recall Notification Letter that was mailed via overnight FedEx mail on February 22, 2019. Letters states problem and action to take: Replacement 1.25mm Hex Driver(s) have been provided to you with this letter. The 1.25mm Hex Driver(s) currently in your kit should be discarded. Please refer to the images on page 2 to locate the driver within your kit. This issue is limited to this 1.25mm Hex Driver(s) only and no other product within the kit is affected by this issue. Complete the Reply Communication form.

    Distribution

    FL, MA, SC, VA

    Quantity

    13 kits hex Driver