BEUDAMED
    FDA Recall 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 · Initiated August 30, 2013

    Recall

    Recall Number
    Z-2211-2013
    Event Number
    66208
    Firm
    Implantech Associates Inc
    FEI Number
    1000142697
    Product Code
    FWP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    August 30, 2013
    Posted
    September 17, 2013
    Terminated
    February 6, 2014
    Address
    6025 Nicolle St, Ste A, Ventura, CA, 93003-7602

    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.

    Action

    Recall was initiated by sending recall notification letters to customers on 08/30/2013 via a combination of 1st class mail, email, and telephone. The recall notification letter, dated August 30, 2013, informs customers of the reason for recall, product description and codes, instructions on what to do with the recalled product and contact information. Within the recall notification letter, a section is provided for responses and signatures.

    Distribution

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

    Quantity

    8