Events

Recall of 3'" Titanium Skull Pin

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

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
    50111
  • Event Risk Class
    Class 2
  • Event Number
    Z-0594-2009
  • Event Date Posted
    2009-01-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-04-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74751
  • 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
    Fixation Accessory - Product Code LYT
  • Reason
    Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products.
  • Action
    Ossur initiated contact with the customers to locate the pins on Sept. 26, 2008 with the Product Manager for this device contacting each consignee by phone. The customers were informed the recall was initiated because the firm was unable to guarantee the sterility of the affected products. Customers were asked to check their inventory for the affected parts. If products were located, they were informed that an Ossur customer service representative will be emailing you with return information any they are to return these pins to the firm as soon as possible. They were also told Ossur does not currently have replacement product available, but they will contact them immediately when they are available. If the products were not located, they were asked to determine where these pins are currently located, if they have been applied to a patient? If so, are they able to track down that patient and bring them in for an evaluation?

Device

3'" Titanium Skull Pin
  • Model / Serial
    Lot Number: 08060410
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA.
  • Product Description
    Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S
  • Manufacturer
    Ossur

Manufacturer

Ossur
  • Manufacturer Address
    Ossur, Grjothals 5, Reykjavik Ireland
  • Source
    USFDA