Events

Recall of Device Recall Citation TMZF HA Hip Stem Right

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by 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
    25085
  • Event Risk Class
    Class 2
  • Event Number
    Z-0350-03
  • Event Initiated Date
    2002-11-12
  • Event Date Posted
    2002-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2003-04-04
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=25131
  • 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, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate - Product Code MEH
  • Reason
    Hip stem fractures in the neck area.
  • Action
    Letters to Surgeons was sent certified mail on Nov. 4, 2002. Letters to Howmedica agents send on Nov. 12, 2002.

Device

Device Recall Citation TMZF HA Hip Stem Right
  • Model / Serial
    Lot Codes: 1148401, 1176101, 1176102, 1205001
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Product was distributed to hospitals and Howmedica Branch reps throughout the US.
  • Product Description
    Citation TMZF HA Hip Stem Left (Femoral Hip Prosthesis) || Catalog No. 6265-5106
  • Manufacturer
    Howmedica Osteonics Corp

Manufacturer

Howmedica Osteonics Corp
  • Manufacturer Address
    Howmedica Osteonics Corp, 359 Veterans Blvd, Rutherford NJ 07070
  • Source
    USFDA