Events

Recall of Stryker Instruments 2.1 mm CrossCut Fissure Bur

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
    53549
  • Event Risk Class
    Class 2
  • Event Number
    Z-0263-2010
  • Event Initiated Date
    2009-10-05
  • Event Date Posted
    2009-11-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-11-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=85822
  • 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
    drill - Product Code DZI
  • Reason
    The cross-cuts are missing on the device, which will result in poor cutting and overheating and/or smoking of the device.
  • Action
    Consignees were notified by letter dated 10/5/09 and requested to return the devices to Stryker. The international account was notified by email.

Device

Stryker Instruments 2.1 mm CrossCut Fissure Bur
  • Model / Serial
    Lots 08311017 and 08336027.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    USA (California, Georgia, Louisiana, Ohio, Wisconsin) and Brazil.
  • Product Description
    Stryker Instruments 2.1 mm Cross-Cut Fissure Bur, carbide extended, sterile; REF 2296-101-621.
  • 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