BEUDAMED
    FDA Recall Terminated

    PHALINX (TM) HAMMERTOE HANDLE, SIZE: SMALL, STYLE: ANGLED, REF 45304012, CONTENTS 1 EACH, RX ONLY

    Recall: Z-1625-2015 · Initiated April 16, 2015

    Recall

    Recall Number
    Z-1625-2015
    Event Number
    71143
    Firm
    Wright Medical Technology, Inc.
    FEI Number
    3010667733
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 16, 2015
    Posted
    May 18, 2015
    Terminated
    October 18, 2018
    Address
    1023 Cherry Rd, Memphis, TN, 38117-5423

    Description

    PHALINX (TM) HAMMERTOE HANDLE, SIZE: SMALL, STYLE: ANGLED, REF 45304012, CONTENTS 1 EACH, RX ONLY

    Reason

    The term DORSAL was laser etched on the incorrect side on some of the angled handles.

    Action

    Wright sent an Urgent Medical Device Recall letter dated April 13, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to examine their inventory for the affected product, send it back to Wright Medical as soon as possible. Contact Customers Service at 901-867-4575 for return instructions and replacement inventory. Customers were instructed to complete the attached response immediately, confirming their receipt of this notice and the status of any product(s) on had, and return a copy by email to [email protected] or fax to 901-867-7401. Customers with questions should call 901-451-6144.

    Distribution

    Nationwide Distribution

    Quantity

    121 units