BEUDAMED
    FDA Recall Terminated

    UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 26016 Femoral Component Size 6, 26018 Femoral Component Size 8 and 26020 Femoral Component Size 10

    Recall: Z-0192-2007 · Initiated July 18, 2006

    Recall

    Recall Number
    Z-0192-2007
    Event Number
    36237
    Firm
    Plus Orthopedics USA
    FEI Number
    3001237832
    Product Code
    HRY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 18, 2006
    Posted
    November 16, 2006
    Terminated
    December 13, 2007
    Address
    10188 Telesis Ct, San Diego, CA, 92121-4779

    Description

    UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014 Femoral Component Size 4, 26016 Femoral Component Size 6, 26018 Femoral Component Size 8 and 26020 Femoral Component Size 10

    Reason

    The modified devices were distributed by Plus Orthopedics USA (Plus USA) June 10, 2003 prior to FDA approval to market of the modified device (Special 510(k) K032052, clearance date July 25, 2003) and withdrawn from the field June 25, 2003.

    Action

    The 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

    California

    Quantity

    12