BEUDAMED
    FDA Recall Terminated

    ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse

    Recall: Z-1749-2015 · Initiated May 18, 2015

    Recall

    Recall Number
    Z-1749-2015
    Event Number
    71297
    Firm
    Orthofix, Inc
    FEI Number
    2183449
    Product Code
    NKB
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    May 18, 2015
    Posted
    June 10, 2015
    Terminated
    October 30, 2015
    Address
    3451 Plano Pkwy, Lewisville, TX, 75056-9453

    Description

    ORTHOFIX Firebird Spinal Fixation System 6.5mm x 55mm Multi-Axial Screw, Standard Implant Grade Titanium Alloy Rx Only Provided Non-Sterile Do Not Reuse

    Reason

    The Firebird Spinal Fixation System 6.5 mm x 55 mm Bone Screw, Self-Tapping is currently mislabeled at the distal tip of the bone screw showing a length measurement of 50 mm instead of 55 mm.

    Action

    Orthofix sent an Urgent Medical Device Recall Notification letter dated May 15, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Affected customers were instructed to inspect their inventory, and identify and remove the recalled product to send back to Orthofix. The distributors are also instructed to provide recall notification to hospitals, surgeons, or other distributors that they have further distributed affected product to. Contact your local Orthofix representative or Orthofix customer service representative at 888-298-5700 for return instructions and shipment information.

    Distribution

    US Distribution to the states of : OK, MD, CA, FL, MI, SC, CO, NY and PA., and Internationally to Asturias Spain.

    Quantity

    45 units