BEUDAMED
    FDA Recall Terminated

    MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm

    Recall: Z-0212-2020 · Initiated September 19, 2019

    Recall

    Recall Number
    Z-0212-2020
    Event Number
    83934
    Firm
    CrossRoads Extremity Systems, LLC
    FEI Number
    3020584246
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    September 19, 2019
    Terminated
    December 2, 2021
    Address
    6055 Primacy Pkwy, Ste 140, Memphis, TN, 38119-5702

    Description

    MotoBand CP, Poly-axial Locking Screw, 3.0mm x 28mm

    Reason

    Potentially includes a 3.0mm x 30mm screw instead of 3.0mm x 28mm screw.

    Action

    CrossRoads Extremity Systems notified customers on about 09/19/2019 via email. The email informed customers that pack-out potentially includes a 3.0mm x 30mm screw instead of 3.0 x 28mm screw. Instructions included to return all affected screws to CrossRoads Extremity Solutions immediately with provided label and return materials authorization.

    Distribution

    Nationwide distribution to AK, CA, FL, GA, IL, MA, MN, NC, NJ, OK, OR, WA.

    Quantity

    36 screws