Events

Recall of CORE

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
    32845
  • Event Risk Class
    Class 2
  • Event Number
    Z-1389-05
  • Event Initiated Date
    2005-08-05
  • Event Date Posted
    2005-08-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-10-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=40931
  • 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
    Driver, Wire, And Bone Drill, Manual - Product Code DZJ
  • Reason
    Potential electrical shock hazard, in that the potential exists for the patient to be exposed to an earth-referenced electrical current.
  • Action
    U.S. customer was notified via recall letter dated August 5, 2005 and international affiliates were notified via email. U.S. account was requested to return the product.

Device

CORE
  • Model / Serial
    All units manufactured July 22, 2005 through July 25, 2005.
  • Product Classification
    Dental Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Virginia, Australia, Canada, England, France, Germany, Japan, Netherlands, Sweden, Switzerland,
  • Product Description
    Stryker brand Consolidated Operating Room Equipment (CORE) System Powered Instrument Driver, REF 5400-50; Model 5400-050-000.
  • 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, Kalamazoo MI 49001
  • Source
    USFDA