Events

Recall of Device Recall 6.5 Cancellous Bone Screw 25 mm

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
    48131
  • Event Risk Class
    Class 2
  • Event Number
    Z-2007-2008
  • Event Initiated Date
    2005-12-20
  • Event Date Posted
    2008-09-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-23
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=70887
  • 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
    Bone screw - Product Code HWC
  • Reason
    The firm has been made aware that one lot of 6.5 cancellous bone screws 25mm was packaged and labeled as 25 mm in length when it maybe 20 mm in length.
  • Action
    The recalling firm sent notification letters and Product Accountability Forms via Fed Ex with return receipt on December 20, 2005. The notification letter described the problem, and asked customers to inventory and quarantine the affected product. Customers were told to return the affected product to Stryker. Contact Stryker at 1-201-831-5825 for assistance.

Device

Device Recall 6.5 Cancellous Bone Screw 25 mm
  • Model / Serial
    Lot Code: 35323605
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    nationwide
  • Product Description
    6.5 Cancellous Bone Screw 25 mm; Responsible Firm on Label: Manufacturer, Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA, A Subsidiary of Stryker Corp., Made in USA; Catalog Number: 2030-6525-1 || The Omnifit bone screws are intended to augment the fixation of compatible acetabular cups.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

Stryker Howmedica Osteonics Corp.
  • Manufacturer Address
    Stryker Howmedica Osteonics Corp., 325 Corporate Dr, Mahwah NJ 07430-2002
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA