BEUDAMED
    FDA Recall Terminated

    Plus Orthopedics Gliding Nail 17mm proximal / 11mm distal, 125 degrees, 180mm; Model Number: 0132073, Plus Orthopedics USA, San Diego, CA 92121

    Recall: Z-0360-2008 · Initiated June 30, 2003

    Recall

    Recall Number
    Z-0360-2008
    Event Number
    45475
    Firm
    Plus Orthopedics USA
    FEI Number
    3001237832
    Product Code
    KTT
    Status
    Terminated
    Root Cause
    Reprocessing Controls
    Initiated
    June 30, 2003
    Posted
    December 8, 2007
    Terminated
    December 13, 2007
    Address
    10188 Telesis Ct, San Diego, CA, 92121-4779

    Description

    Plus Orthopedics Gliding Nail 17mm proximal / 11mm distal, 125 degrees, 180mm; Model Number: 0132073, Plus Orthopedics USA, San Diego, CA 92121

    Reason

    The device was produced without the required distal locking hole

    Action

    The initial depth of the withdrawal action taken in June, 2003 ,was to the distributor (agent) level. Plus USA contacted individual agent sites showing inventory of the affected article numbers on hand and requested that those items be returned to Plus USA.

    Distribution

    Nationwide: AZ and ID

    Quantity

    3