Events

Recall of Device Recall Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft

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

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
    35046
  • Event Risk Class
    Class 2
  • Event Number
    Z-0849-06
  • Event Initiated Date
    2006-03-08
  • Event Date Posted
    2006-05-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45188
  • 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
    Screwdriver, Skullplate - Product Code GXL
  • Reason
    Medtronic neurosurgery has initiated this action because it was determined that two lots of the modular screwdriver blade components may exhiibt burrs along the tips of the screwdriver, which may prevent adequate engagement with the associated screws.
  • Action
    Medtronic Neurosurgery sent a Sales Representative Notification letter to the applicable Medtronic Sales Representative by mail and fax on March 8, 2006. A Sales Representative Notification Letter was provided to each Medtronic Sales Representative who had received the product or is responsible for an account who has received the product. This letter informed the applicable Sales Representative of the action and instructed them how to complete the Sales Representative Customer Product Accountability Letter. A Sales Representative Customer Product Accountability Letter was provided to each Medtronic Sales Representative who has received the product or is responsible for an account who has received the product. This letter requests the current product status, i.e., has the product been used, discarded or will it be returned to Medtronic Neurosurgery. Each letter will be individualized for each customer indicating the specific catalog number(s), lot number(s) and quantity that were shipped to that customer. It is the firm''s intention to have the Sales Representative exchange all affected product with replacement product during this process.

Device

Device Recall Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft
  • Model / Serial
    TV 59965,  TV 59967
  • Product Classification
    Neurological Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    The product was distributed to the following states: Florida, Illinois, New York, Pennsylvania, Tennessee
  • Product Description
    Medtronic (TiMesh), Screwdriver, 1.5mm, Cruciate, Self Tapping Shaft, Catalog Number 8001215 || The 8001215 Screwdriver is a stainless steel part designed for use with cruciate-style screws in the firm''s TiMesh System. The product is sold in non-sterile, single unit packages. They are re-usable, and autoclavable.
  • Manufacturer
    Medtronic Neurosurgery

Manufacturer

Medtronic Neurosurgery
  • Manufacturer Address
    Medtronic Neurosurgery, 125 Cremona Dr, Goleta CA 93117-5503
  • Source
    USFDA