Events

Recall of Device Recall TransFx External Fixation System Drill Bit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    51924
  • Event Risk Class
    Class 2
  • Event Number
    Z-1535-2009
  • Event Initiated Date
    2009-05-01
  • Event Date Posted
    2009-06-30
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-11-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81658
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Multiple Component Metallic Bone Fixation Appliance - Product Code LXT
  • Reason
    Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
  • Action
    Distributors and consignees were notified by an Urgent: Device Recall letter dated 5/1/09. Consignees were advised to stop using the device and quarantine it immediately. Distributors were instructed to carry out a physical count of all affected product and record the data on the Inventory Return Certification Form; fax a copy of the completed form to Zimmer, Inc.; and return recalled product along with the Inventory Return Certification Form to the firm.

Device

Device Recall TransFx External Fixation System Drill Bit
  • Model / Serial
    Lots 56454675, 70185900, 70238100,70247500 and 70249700.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution -- USA, Australia, Canada, El Salvador, England, Germany, Latin America, and Singapore.
  • Product Description
    TransFx External Fixation System Drill Bit, Quick Connect, 3.5 mm diameter, 195 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-61. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. || For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Manufacturer Address
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA