BEUDAMED
    FDA Recall Terminated

    STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures.

    Recall: Z-1786-2013 · Initiated May 20, 2013

    Recall

    Recall Number
    Z-1786-2013
    Event Number
    65573
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    HST
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    May 20, 2013
    Posted
    July 22, 2013
    Terminated
    August 28, 2013
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    STERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures.

    Reason

    A bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release reliability testing; a replacement bushing passed reliability testing and was substituted per a change order. The change order authorized use of the substitute bushing in assembly of the Fine Traction Accessory; however, inadvertently the new part was not implemented. During complaint evaluati

    Action

    STERIS Account Managers notified affected customers via onsite visits. All consignees were notified as of 5/29/2013. Customers were instructed to return affected product for a replacement unit.

    Distribution

    USA Nationwide Distribution in the states of CO, KY, LA, VA, and WI. The affected product was also distributed to Canada.

    Quantity

    16 units