BEUDAMED
    FDA Enforcement Class II Terminated

    Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region.

    Recall: Z-2211-2013 · Reported September 25, 2013

    Enforcement

    Recall Number
    Z-2211-2013
    Event ID
    66208
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Implantech Associates Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 25, 2013
    Initiation Date
    August 30, 2013
    Classification Date
    September 17, 2013
    Termination Date
    February 6, 2014
    Address
    6025 Nicolle St Ste A, N/A, Ventura, CA, 93003-7602, United States

    Description

    Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region.

    Reason

    Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (Lot # 848488 and 850156), after determining that the devices from the lot numbers do not conform to the dimensional requirements for the TSCII-M.

    Code Info

    Catalog Number: TSCII-M Lot Numbers: 848488 and 850156

    Distribution

    Worldwide distribution: US (nationwide) including states of NY, KY, and CO, and the country of Israel.

    Quantity

    8