BEUDAMED
    FDA Recall Terminated

    DRL System Trays comprised of DRLock Bone Fixation Plates, Pegs, and Screw Systems: Four Plate Styles include: Part Numbers: DRV-002-0L Fixed Short Left Plate, DRV-002-0R , Fixed Short Right Plate, DRV-002-1L, Fixed Standard Left Plate, and DRV-002-1R, Fixed Standard Right Plate; Distal Screw Part Numbers: DRV-021-24-10, -12, -14, -16, -18, -20, -22 and -24; Distal Peg Part Number: DRV-121-20-10, -12, -14, -16, -18, -20, -22, and -24; All screw caddies and any distal screw and peg inventory not yet added to screw caddies, Ortho Helix Surgical Designs, Inc., Akron, OH

    Recall: Z-0136-2008 · Initiated September 4, 2007

    Recall

    Recall Number
    Z-0136-2008
    Event Number
    44883
    Firm
    OrthoHelix Surgical Designs Inc
    FEI Number
    3000718467
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Component change control
    Initiated
    September 4, 2007
    Posted
    December 19, 2007
    Terminated
    May 20, 2011
    Address
    1815 W Market St, Ste 205, Akron, OH, 44313-7018

    Description

    DRL System Trays comprised of DRLock Bone Fixation Plates, Pegs, and Screw Systems: Four Plate Styles include: Part Numbers: DRV-002-0L Fixed Short Left Plate, DRV-002-0R , Fixed Short Right Plate, DRV-002-1L, Fixed Standard Left Plate, and DRV-002-1R, Fixed Standard Right Plate; Distal Screw Part Numbers: DRV-021-24-10, -12, -14, -16, -18, -20, -22 and -24; Distal Peg Part Number: DRV-121-20-10, -12, -14, -16, -18, -20, -22, and -24; All screw caddies and any distal screw and peg inventory not yet added to screw caddies, Ortho Helix Surgical Designs, Inc., Akron, OH

    Reason

    Seat/Fit problems: The heads of the distal screws/pegs rest above the surface of the distal plate after the screws/pegs are fully tightened.

    Action

    On 9/4/2007, OrthoHelix mailed an Important Recall Notification letters via certified mail to all direct accounts. The notification instructed all accounts to examine their inventory and return all recalled product, identified within the notification, to OrthoHelix for replacement.

    Distribution

    Nationwide; including states of IL, CA, VA, TX, MD, UT, GA, CO, NJ, OH, & WI.

    Quantity

    267 plates/52 DRL System Trays