BEUDAMED
    FDA Enforcement Class II Terminated

    APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna.

    Recall: Z-0150-2015 · Reported November 5, 2014

    Enforcement

    Recall Number
    Z-0150-2015
    Event ID
    69433
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medartis, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 5, 2014
    Initiation Date
    October 1, 2014
    Classification Date
    October 30, 2014
    Termination Date
    August 6, 2015
    Address
    127 W Street Rd Ste 203, N/A, Kennett Square, PA, 19348-1698, United States

    Description

    APTUS Ulna Shortening 2.5 Product Usage: APTUS Ulna Shortening 2.5 Plates are indicated for fractures and osteotomies, in particular for the ulna.

    Reason

    A recall of the APTUS Ulna Shortening 2.5 instrument was initiated due to three (3) complaints of breakage of the temporary tension bolt.

    Code Info

    Part no. A-2791.05, lot no. 14125026

    Distribution

    US Nationwide Distribution in the states of WV, IL, CT, AZ, and WA.

    Quantity

    44