BEUDAMED
    FDA Recall Terminated

    DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an aluminum tray case that contains the following: IMPLANTS: 6 stainless steel plates (2-lefts, 2-rights, and 1-right long and 1-right left), 48 distal locking-screws (ranging from 10-24mm), 32 distal locking pegs, 36 proximal locking screws, 24 proximal non-locking screws. INSTRUMENTS: 2 Bending Pliers*, 1 Bone Reduction Forcep*, 2 Hohmann Retractors *, 1 Ratchet Handle*, 1 Periosteal Elevator*, 1 Dingman Elevator *, 1 K & K Elevator *, four Driver tips *, five drill guides*, 2-1.6 Drill Bits *, 2-2.3 Drill Bits *, 1 Plate Holder Verbruge *, 2 Depth Gages *, 6 K wires.

    Recall: Z-0349-2007 · Initiated August 3, 2006

    Recall

    Recall Number
    Z-0349-2007
    Event Number
    36843
    Firm
    OrthoHelix Surgical Designs Inc
    FEI Number
    3000718467
    Product Code
    HRS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 3, 2006
    Posted
    January 19, 2007
    Terminated
    September 10, 2012
    Address
    1815 W Market St, Ste 205, Akron, OH, 44313-7018

    Description

    DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an aluminum tray case that contains the following: IMPLANTS: 6 stainless steel plates (2-lefts, 2-rights, and 1-right long and 1-right left), 48 distal locking-screws (ranging from 10-24mm), 32 distal locking pegs, 36 proximal locking screws, 24 proximal non-locking screws. INSTRUMENTS: 2 Bending Pliers*, 1 Bone Reduction Forcep*, 2 Hohmann Retractors *, 1 Ratchet Handle*, 1 Periosteal Elevator*, 1 Dingman Elevator *, 1 K & K Elevator *, four Driver tips *, five drill guides*, 2-1.6 Drill Bits *, 2-2.3 Drill Bits *, 1 Plate Holder Verbruge *, 2 Depth Gages *, 6 K wires.

    Reason

    The 48 distal locking-screws (ranging from 10-24mm) contained in the kit are not within established specifications, specifically the minor diameter of the screws are undersized.

    Action

    The recalling firm contacted all consignees by phone on or about 8/3/06.

    Distribution

    The product was distributed to 5 consignees located in the U.S.: Archway Medical, Columbia, SC; Gulf Coast Surgical, Stafford, TX; Vaugham Medical, Wheat Ridge, CO; Belemy Medical, Cleveland, OH; and Crystal Clinic, Akron, OH.

    Quantity

    180