Events

Recall of UHR

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
    45854
  • Event Risk Class
    Class 2
  • Event Number
    Z-0631-2008
  • Event Initiated Date
    2007-10-26
  • Event Date Posted
    2008-03-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2010-01-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=66314
  • 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
    Hip Prosthesis Component - Product Code KWL
  • Reason
    Incorrect part: device may have an incorrect locking ring assembled with the uhr bipolar head.
  • Action
    Stryker sent Urgent Product Hold letters to US branches/agencies and hospitals on October 26, 2007 advising them to quarantine the product from these lots, and Urgent Product Recall letters on November 2, 2007 advising them to return the devices to Stryker. International distributors were sent an advisory on November 6, 2007.

Device

UHR
  • Model / Serial
    Ref No: Description: Lot Code:  UH1-48-26 UHR BIPOLAR 26X48mm ELYMLA UH1-48-26 UHR BIPOLAR 26X48mm LXWMHD UH1-48-26 802MPD UH1-48-26 E99MPD UH1-48-26 RDRMEA UH1-48-26 RDVMEA
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA, Canada, China, India, Australia, Korea, Singapore, Taiwan, Sweden, Germany, Netherlands, France, Spain, Italy, Poland, South Africa, and England.
  • Product Description
    Stryker Orthopaedics; UHR Universal Bipolar Component; 26 x 48 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
  • 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