BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1487-2017 · Initiated February 16, 2017

    Recall

    Recall Number
    Z-1487-2017
    Event Number
    76687
    Firm
    Crossroads Extremity Systems Llc
    FEI Number
    3020584246
    Product Code
    JDR
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 16, 2017
    Posted
    March 20, 2017
    Terminated
    April 27, 2017
    Address
    6055 Primacy Pkwy, Ste 140, Memphis, TN, 38119-5702

    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.

    Action

    The firm notified their distributors by email on 02/16-17/2017. The distributors were asked to return the unused lot #101866. The firm also contacted the implanting surgeons either by visit or telephone about the potential for an incorrect size of the implant and asked if there were any adverse events.

    Distribution

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

    Quantity

    20 units