Events

Recall of Device Recall Stryker 5.0mm Round Fluted Bur Aggressive

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
    68331
  • Event Risk Class
    Class 2
  • Event Number
    Z-1758-2014
  • Event Initiated Date
    2014-05-22
  • Event Date Posted
    2014-06-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-05-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127417
  • 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
    Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
  • Reason
    There may be missing notches, partial notches or no notches at all in some cutting accessories that are used with the elite" attachments.
  • Action
    Stryker Instruments sent an URGENT MEDICAL DEVICE RECALL notification letter dated May 22, 2014, to the consignees. Recall notification included affected product description and identification, reason for recall, risk to health, and actions to be taken by the customers. Customers will be instructed to review the notification, quarantine unused product and to return a signed Business Reply Form. They will be advised that a Stryker Representative will be sent to their facility to inspect any affected product on hand. Once product is inspected by the Stryker Representative, they can return conforming product back to stock, for normal use. Non-conforming product will be removed from the facility by a Stryker Representative following the inspection process. The Stryker Representative will send the product to the manufacturer for destruction. For questions regarding this recall please contact Stryker Instruments: Kara Spath 269-389-4518 kara.spath@stryker.com

Device

Device Recall Stryker 5.0mm Round Fluted Bur Aggressive
  • Model / Serial
    Part Number 5820-10-250, Lot Numbers 13336017, 13339017, 13340017, 13344017
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (nationwide)
  • Product Description
    Stryker 5.0mm Round Fluted Bur Aggressive || Sterile || Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
  • 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, Portage MI 49002-9704
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA