Events

Recall of Device Recall Stryker 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
    74639
  • Event Risk Class
    Class 2
  • Event Number
    Z-2238-2016
  • Event Initiated Date
    2016-06-24
  • Event Date Posted
    2016-07-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-03-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148080
  • 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
    A variation in flute depth on the routers was observed. the variation in flute depth may cause the routers to be more susceptible to breakages. risk to health: injury to critical soft tissue requiring surgical intervention may occur.
  • Action
    Stryker sent an Urgent Medical Device Recall Notification letter dated June 24, 2016, to the affected customers via courier, and to Sales Representatives and international affiliates via e-mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions regarding this recall, please contact Stryker Instruments at 269-389-2921.

Device

Device Recall Stryker CORE
  • Model / Serial
    Lot numbers: 15077027, 15077067, 15077097, 15078087, 15105017, 15108017, 15108047, 15108077, 15108087, 15108097, 15146017, 15146027, 15146037, 15146047
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) Netherlands, Canada, Japan, Switzerland, and United Kingdom
  • Product Description
    2.3MM Tapered Router, || Product Number 5407-FA2-023 || A router is a cutting accessory used in the following medical applications: Neuro; Spine; Ear, Nose, and Throat || (ENT)/Otology /Neurotology/ Otorhinolaryngology; Craniofacial (bones of the skull and supraorbital region); and || Sternotomy. They are intended to be used with the Stryker CORE" system.
  • 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