BEUDAMED
    FDA Enforcement Class II Terminated

    Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512

    Recall: Z-2535-2016 · Reported August 24, 2016

    Enforcement

    Recall Number
    Z-2535-2016
    Event ID
    74799
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Straumann Manufacturing, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    August 24, 2016
    Initiation Date
    July 14, 2016
    Classification Date
    August 12, 2016
    Termination Date
    November 20, 2020
    Address
    60 Minuteman Rd, N/A, Andover, MA, 01810-1008, United States

    Description

    Straumann Bone Level Implant, ¿ 4.1mm RC, SLA¿ 12mm, TiZr, NTP Article Number: 021.4512

    Reason

    Misalignment with the Loxim transfer piece markings, the positioning of the implant will be incorrect for optimal restoration

    Code Info

    Lot Number: LT123

    Distribution

    Nationwide Distribution.

    Quantity

    33 pieces