Events

Recall of Device Recall Stryker Howmedica Osteonics Corp.

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
    64306
  • Event Risk Class
    Class 2
  • Event Number
    Z-0919-2013
  • Event Initiated Date
    2012-12-20
  • Event Date Posted
    2013-03-08
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115789
  • 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 LXH
  • Reason
    Reports of handle fracture and subsequent disassociation of cam assembly subcomponents during use.
  • Action
    Stryker Orthopaedics sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" dated December 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at (201) 972-2100 for questions regarding this issue.

Device

Device Recall Stryker Howmedica Osteonics Corp.
  • Model / Serial
    Catalog Number: 6266-0-100 Lot Code: RD6W017, RD7L234X, RD7L234, RD7L235, RD5T305A, RD6W017J, RD6W017A, RD5T307, RD5T305T, RD5T305M, RD5T305L, RD5T306X, RD5T305, RD5T306
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution.
  • Product Description
    Command Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
  • 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