BEUDAMED
    FDA Enforcement Class II Terminated

    Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve ¿ 4.8 mm is used to transfer the implant from the packaging to the patient via a plug-in connection and screwed in manually or mechanically.

    Recall: Z-1390-2019 · Reported May 29, 2019

    Enforcement

    Recall Number
    Z-1390-2019
    Event ID
    82675
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Thommen Medical AG
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 29, 2019
    Initiation Date
    April 3, 2019
    Classification Date
    May 22, 2019
    Termination Date
    August 12, 2019
    Address
    Eschenweg 3, N/A, Bettlach, N/A, N/A, Switzerland

    Description

    Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve ¿ 4.8 mm is used to transfer the implant from the packaging to the patient via a plug-in connection and screwed in manually or mechanically.

    Reason

    Dental adaptor does not conform to specifications. The dental coupling of the adapter can become deformed when being inserted into the implant may make it difficult to remove the adapter from its counterpart (e.g. the handpiece).

    Code Info

    Lot number:17415 UDI: 07640182640705

    Distribution

    US Nationwide distribution in the state of OH.

    Quantity

    15 US