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-0623-2008
  • Event Initiated Date
    2007-10-26
  • Event Date Posted
    2008-03-20
  • Event Status
    Terminated
  • Event Country
  • Event Terminated Date
    2010-01-27
  • Event Source
    USFDA
  • Event Source URL
  • 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:  UH1-44-28 UHR BIPOLAR 28X44mm 3K4MMD UH1-44-28 UHR BIPOLAR 28X44mm 5P0MLA UH1-44-28 UHR BIPOLAR 28X44mm JEMMNA UH1-44-28 04YMPD UH1-44-28 0YHMMD UH1-44-28 247MMD UH1-44-28 29EMPD UH1-44-28 2HYMRA UH1-44-28 66NMKD UH1-44-28 6W5MPD UH1-44-28 6W6MPD UH1-44-28 8XEMPD UH1-44-28 8XKMPD UH1-44-28 9W0MJA UH1-44-28 D05MKD UH1-44-28 ED8MND UH1-44-28 EP2MPA UH1-44-28 K57MND UH1-44-28 K6LMND UH1-44-28 LA6MPA UH1-44-28 V13MLD UH1-44-28 V17MLD
  • Product Classification
  • 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; 28 x 44 mm, Hip Prosthesis Component, Stryker Howmedica Osteonics Corp., Mahwah, NJ 07430
  • Manufacturer

Manufacturer

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