Events

Recall of Device Recall Stryker TOM

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

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
    37067
  • Event Risk Class
    Class 2
  • Event Number
    Z-0521-2007
  • Event Initiated Date
    2006-12-22
  • Event Date Posted
    2007-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-06-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=49843
  • 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
    bone mill - Product Code LXH
  • Reason
    Metal shavings come off of the plug as a result of friction between the plug and the cutting cylinder, and may be mixed with the milled bone chips.
  • Action
    Consignees were notified via recall letter dated 12/22/06 which instructed them to quarantine the product and to contact the firm for further instructions.

Device

Device Recall Stryker TOM
  • Model / Serial
    Lots G4C00F72HN, G5H00F72HN, G7T00F72HN, G8W00F72HN and G9700F72HN.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide.
  • Product Description
    Stryker Tom Tessier Osseous Microtome: Plug for Bone Mill Systems (Parts 01-15400 and 01-15401), Stryker Leiblinger Inc., Kalamazoo, MI; Part 01-15407.
  • Manufacturer
    Stryker Leibinger USA

Manufacturer

Stryker Leibinger USA
  • Manufacturer Address
    Stryker Leibinger USA, 750 Trade Center Way Ste 200, Portage MI 49002-0482
  • Source
    USFDA