BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0212-2020 · Reported October 30, 2019

    Enforcement

    Recall Number
    Z-0212-2020
    Event ID
    83934
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    CrossRoads Extremity Systems, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 30, 2019
    Initiation Date
    September 19, 2019
    Classification Date
    October 24, 2019
    Termination Date
    December 2, 2021
    Address
    6055 Primacy Pkwy Ste 140, Memphis, TN, 38119-5702, United States

    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.

    Code Info

    Part Number: 15PL-3028, Lot Number: 500750

    Distribution

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

    Quantity

    36 screws