Events

Recall of THOR

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

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
    53606
  • Event Risk Class
    Class 2
  • Event Number
    Z-0452-2010
  • Event Initiated Date
    2009-10-02
  • Event Date Posted
    2009-11-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-01-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86075
  • 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
    spinal implant component - Product Code KWQ
  • Reason
    Surgeons may apply an accidental axial torque to and/or over-angulate the all-in one guide while implanting the screw. this may cause the screw not to seat properly in the locking ring and may cause the thor screwdrivers to twist or break at the tip.
  • Action
    Recall notification letters were sent to all Stryker branches, Hospital Risk Management and Surgeons on October 19, 2009 by Federal Express. Questions are to be directed to Tiffani Rogers, Regulatory Compliance Manager at 201-760-8206.

Device

THOR
  • Model / Serial
    Catalog number 48036561, all lots
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide
  • Product Description
    Stryker Thor Anterior Plating System; || Non Sterile || Thor Standard Long Screw 6.5 x 61MM, spinal implant component
  • Manufacturer
    Stryker Spine

Manufacturer

Stryker Spine
  • Manufacturer Address
    Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA