Events

Recall of Device Recall HA Generation II

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
    44780
  • Event Risk Class
    Class 2
  • Event Number
    Z-0073-2008
  • Event Initiated Date
    2007-08-30
  • Event Date Posted
    2007-10-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2008-09-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=64357
  • 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 acetabular component - Product Code MEH
  • Reason
    Stryker orthopaedics had identified that specific lots of trident psl acetabular shells may have a dimensional discrepancy. the deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one side and will decrease the gap between shell and liner on the opposing side, resulting in interference.
  • Action
    Recall notification letters were sent out on August 30, 2007 with return receipt.

Device

Device Recall HA Generation II
  • Model / Serial
    540-11-52E TRIDENT PSL HA SOLID BACK 52mm 8NKMJD 540-11-54F TRIDENT PSL HA SOLID BACK 54mm 3H7MJD 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 78AMJD 540-11-58G TRIDENT PSL HA SOLID BACK 58mm 9T9MJD 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 4THMJD 540-11-66I TRIDENT PSL HA SOLID BACK 66mm 4TJMJD 540-11-66I TRIDENT PSL HA SOLID BACK 66mm RLKMHD 540-11-72J TRIDENT PSL HA SOLID BACK 72mm 1WNMJD
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Product was distributed nationwide and one unit to Brazil.
  • Product Description
    HA Solid Back Acetabular Shell; || Arc Deposited HA Coated Included Dome hole Plug; Hip prosthesis component. || Sterile; made in USA; || Howmedica Osteonics Corp.; || 325 Corporate Drive; || Mahwah, NJ 07430 || A Subsidiary of Stryker Corp.
  • 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