Events

Recall of Device Recall System 6 Aseptic Housing

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
    70298
  • Event Risk Class
    Class 2
  • Event Number
    Z-1066-2015
  • Event Initiated Date
    2015-01-07
  • Event Date Posted
    2015-02-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=132898
  • 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
    Stryker is recalling system 6 aseptic housing, due to a failed continuous bond line test from a housing without a continual weld. customers are instructed to return recalled product to stryker.
  • Action
    Stryker sent notice to customers via Fed ex overnight on 1/16/2015, regarding its voluntary recall of Stryker System 6 Aseptic Housings because the laser welder may have failed to produce a continuous bond line for the four specific lots: 13205, 13209, 13210, 13212. Customers are instructed to discontinue use, complete the business reply form, and return all recalled product. Customers may contact Kara Spath at 269-389-4518, or kara.spath@stryker.com.

Device

Device Recall System 6 Aseptic Housing
  • Model / Serial
    Part No. 6126-120-000, Lots 13205, 13209, 13210, 13212
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-US (nationwide) including Puerto Rico and the states of AR, CA, CO, FL, GA, HI, MD, NC, NY, PA, SC, TX, and VA, and the countries of Australia, Canada, Switzerland, Hong Kong, South Africa, Chile, Korea, Poland, India, Colombia, The Netherlands, and France.
  • Product Description
    System 6 Aseptic Housing. || The Stryker System 6 Aseptic Housings provide a sterile enclosure for the Stryker Non-sterile Battery. Accessory for powered orthopedic surgical instrument.
  • 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