Events

Recall of Reamer THandle

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
    50099
  • Event Risk Class
    Class 2
  • Event Number
    Z-0794-2010
  • Event Initiated Date
    2005-08-08
  • Event Date Posted
    2010-02-17
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-02-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=74721
  • 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
    Orthopedic manual surgical instrument - Product Code HTO
  • Reason
    Stryker orthopaedics learned that the t-handles have the potential to not engage and not attach to the reamer properly.
  • Action
    Stryker Orthopaedics issued notification dated August 8, 2005 via Federal Express. Consignees were informed of the affected product and necessary steps to take for product replacement. For further information, contact Stryker at (201) 831-5825.

Device

Reamer THandle
  • Model / Serial
    Catalog Number: 2124-2100; Lot Codes: ALZH05 and ALZE32.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- United States, Germany, The Netherlands, Spain, Italy, Switzerland, Poland, Romania, South Africa, England, Columbia, Venezuela, Japan and Australia.
  • Product Description
    Navigation Reamer T-handle; Non Sterile; Howmedica Osteonics, 325 Corporate Drive, Mahwah, NJ 07430. || Intended for use in orthopaedic surgery to interface with various cutting instruments and drivers.
  • 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