BEUDAMED
    FDA Enforcement Class II Terminated

    MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.

    Recall: Z-1487-2017 · Reported March 29, 2017

    Enforcement

    Recall Number
    Z-1487-2017
    Event ID
    76687
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Crossroads Extremity Systems Llc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 29, 2017
    Initiation Date
    February 16, 2017
    Classification Date
    March 20, 2017
    Termination Date
    April 27, 2017
    Address
    6055 Primacy Pkwy Ste 140, Memphis, TN, 38119-5702, United States

    Description

    MotoCLIP(TM) Super Elastic Fusion System, Size 18mm x 14mm x 14mm, REF 1442-1814, Rx Only, STERILE R.

    Reason

    Seven 18mm x 18mm x 18 mm implants had been placed in kits, packed and labeled as 18mm x 14mm x 14mm.

    Code Info

    Lot Number 101868

    Distribution

    Al, FL, IN, Il, NE, TX, NM, CO, AZ

    Quantity

    20 units