Events

Recall of Device Recall Implant Extraction Set Implant Extraction Guide Module One & Two

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

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
    55049
  • Event Risk Class
    Class 2
  • Event Number
    Z-1443-2010
  • Event Initiated Date
    2010-03-02
  • Event Date Posted
    2010-04-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-08-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=89794
  • 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
    Extractor - Product Code HWB
  • Reason
    Literature did not include the design change to a smaller cannulation diameter.
  • Action
    An Urgent Correction - Operative Technique letter was sent to direct accounts, Hospital Risk Management, Chief of Orthopaedics and Surgeons that use the Gamma3 system. Notification letters were sent via Federal Express on March 2, 2010. The letter identified the product and described the issue. It also discussed the potential hazards and risk mitigation. Customers are to contact Customer Service at 1-866-OR-ASSIST or any of the other firm representatives listed in the letter.

Device

Device Recall Implant Extraction Set Implant Extraction Guide Module One & Two
  • Model / Serial
    LIES-OT
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Literature for Implant Extraction Set - Implant Extraction Guide Module One & Two. || Lists and describes the instruments which are in the Implant Extraction Set and the general application of these instruments for hardware removal.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA