Events

Recall of Citation AT Femoral Stem

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
    33361
  • Event Risk Class
    Class 2
  • Event Number
    Z-0109-06
  • Event Initiated Date
    2005-08-24
  • Event Date Posted
    2005-11-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-05
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=41816
  • 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
    Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish - Product Code MAY
  • Reason
    The v40 femoral head may not properly engage on the referenced v40 cobal chrome femoral hip stems.
  • Action
    A urgent product recall notification was sent out to all hospitals on August 24, 2005, branches and agencies by first class mail. The action is limited only to that product manufactured in the Stryker Ireland facility for the product families indicated.

Device

Citation AT Femoral Stem
  • Model / Serial
    Catalog #-- Description-- # of lots:  6265-2-102, Citation AT Left Hip Stem #2, 11 lots; 6265-2-103, Citation AT Left Hip Stem #3, 15 lots; 6265-2-104, Citation AT Left Hip Stem #4, 31 lots; 6265-2-105, Citaiton AT Left Hip Stem #5, 31 lots; 6265-2-112, Citation AT Left Hip Stem #2, 1 lot # P4GFD; 6265-2-113, Citation AT Left Hip Stem #3, 49 lots; 6265-2-114, Citation AT Left Hip Stem #4 , 27 lots; 6265-2-115, Citation AT Left Hip Stem #5, 23 lots.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    nationwide
  • Product Description
    Citation AT Femoral Stem
  • 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