BEUDAMED
    FDA Recall Terminated

    Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001).

    Recall: Z-0475-2016 · Initiated June 9, 2014

    Recall

    Recall Number
    Z-0475-2016
    Event Number
    72695
    Firm
    Arthrosurface, Inc.
    FEI Number
    3004154314
    Product Code
    LZJ
    Status
    Terminated
    Root Cause
    Process change control
    Initiated
    June 9, 2014
    Posted
    December 23, 2015
    Terminated
    February 5, 2016
    Address
    28 Forge Pkwy, Franklin, MA, 02038

    Description

    Total Toe Instrument Kit, Labeled in part: "Instrument Set, 15mm Toe, Dorsal Flange Combi" Part Number: 9000-3002 The component in question is the hex driver (part number 2009-4001).

    Reason

    An oversight in the implementation of the design change record resulted in outdated components being shipped to customers. The component did not pass a half-cycle sterilization.

    Action

    The distributors were verbally notified, and replacement Rev F Hex Drivers sent to the locations of the kits. The kits had been moved in preparation for upcoming surgeries, but the Drivers were replaced prior to any additional surgery taking place. No affected product remains in the field. For further questions, please call (508) 520-3003.

    Distribution

    US Distribution to the states of : PA, WV and CA.

    Quantity

    3 units