Events

Recall of Device Recall Stryker Orthopaedics, Duracon XCelerate

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Howmedica Osteonics Corp..

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
    54083
  • Event Risk Class
    Class 2
  • Event Number
    Z-1586-2010
  • Event Initiated Date
    2009-12-03
  • Event Date Posted
    2010-05-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87414
  • 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
    manual orthopedic surgical instrument - Product Code LXH
  • Reason
    The ceramic guide rails, within the xcelerate 4:1 ceramic cutting blocks, may fracture and displace from the block.
  • Action
    Urgent Product Recall Letters were sent on December 3, 2009 via Federal Express to Stryker Branches/Agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. Foreign accounts were notitied on December 7, 2009. Questions or comments should be addressed to Colleen O'Meara at 201-972-2100.

Device

Device Recall Stryker Orthopaedics, Duracon XCelerate
  • Model / Serial
    Catalog number: 8000-7030, all lots
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, Sweden, Ireland, Canada, Hong Kong, Germany, Spain, India, Australia, Italy, New Zealand, and United Kingdom.
  • Product Description
    Stryker Orthopaedics, Duracon 4:1 Ceramic Cutting Block ML; || XCelerate cutting block for distal femur in orthopaedic surgery, Non-Sterile.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah NJ 07430
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA