BEUDAMED
    FDA Recall 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 · Initiated October 1, 2014

    Recall

    Recall Number
    Z-0150-2015
    Event Number
    69433
    Firm
    Medartis, Inc.
    FEI Number
    3005215824
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    October 1, 2014
    Posted
    October 30, 2014
    Terminated
    August 6, 2015
    Address
    127 W Street Rd, Ste 203, Kennett Square, PA, 19348-1698

    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.

    Action

    The recall is being extended to end user level of distribution. The sales representatives, customers and a distributor were notified via phone or email on September 19th and notified of the recall via US mail on 10/1/14. US customers, distributors, and sales representatives were instructed to return the affected instrument kits to the importer Medartis, Inc. via transport agency.

    Distribution

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

    Quantity

    44