Events

Recall of Device Recall Stryker Bur Guard REF 2296301

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

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
    55923
  • Event Risk Class
    Class 2
  • Event Number
    Z-2420-2010
  • Event Initiated Date
    2010-06-02
  • Event Date Posted
    2010-09-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-04-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=92243
  • 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
    Instrument, surgical, orthopedic, ac-powered motor and accessory/attachment - Product Code HWE
  • Reason
    The reason for the field action is that the inner diameter of the bur guards may be out of specification. if there is excess material on the inside of the bur guard at the location where the guard tapers, it may come into contact with the nose cone of the drill. this could result in an injury or burn to the patient and/or user.
  • Action
    Stryker Instruments sent an Urgent Medical Device Recall Notification dated June 10, 2010, to their customers. The letter described the product the problem and the action to be taken by the customers. The customers were instructed to: 1) immediately review this recall notification. 2) forward this letter and the attached Business Reply Form (BRF) to all affected locations. 3) Immediately check and quarantine any affected product found. 4) Destroy all affected product by breaking off at least 3 of the tabs on the bur guard and then dispose of the affected product in normal trash. 5) Complete and sign the BRF and fax to Stryker Instruments Regulatory Department, 866-521-2762. NOTE: Upon receipt of the BRF, a replacement bur guard will be sent to the customer's account for each affected bur guard destroyed. For questions regarding this recall please contact Stryker Instruments: 1-800-800-4236, ext. 3808 jennifer.mars@stryker.com

Device

Device Recall Stryker Bur Guard REF 2296301
  • Model / Serial
    Replace by dates of May 2009 through August 2010
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: US AND COUNTRIES OF SCANDINAVIA, AUSTRALIA, CANADA, CHILE, CHINA, BRAZIL, FRANCE, GERMANY, GREECE, SOUTH AFRICA, ITALY, JAPAN, MEXICO, SWITZERLAND, PORTUGAL, SINGAPORE and UK.
  • Product Description
    Stryker Bur Guard REF 2296-301, Stryker Instruments, Kalamazoo, MI (USA) || The Impaction Bur Guard is intended to be used with the Impaction Drill. The drill is used for surgical procedures involving precision drilling and cutting of bone and hard tissue. The bur guard covers the nose of the handpiece and the shaft of the cutting accessory to prevent exposure to heat and moving parts, as well as minimize bur whip and handpiece vibration.
  • Manufacturer
    Stryker Instruments Div. of Stryker Corporation

Manufacturer

Stryker Instruments Div. of Stryker Corporation
  • Manufacturer Address
    Stryker Instruments Div. of Stryker Corporation, 4100 E. Milham Ave., Kalamazoo MI 49001
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA