Events

Recall of Hipstar TMZF

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
    45982
  • Event Risk Class
    Class 2
  • Event Number
    Z-0475-2008
  • Event Date Posted
    2007-12-14
  • 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=66604
  • 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 Stem Protocol - Product Code LPH
  • Reason
    Mis-labeling: an error on page 4 of the hipstar protocol was found. in the table for compatible heads, the 40 mm diameter heads with a neck length of +12 should have been omitted.
  • Action
    Urgent Product Correction Letters, dated 10/17/2007 were sent on 10/17/07by Federal Express to all Stryker Branches/Agencies who had received the protocol. The branches were instructed to quarantine and destroy the protocols.

Device

Hipstar TMZF
  • Model / Serial
    Literature # LPS60 (Lot code n/a)
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide:The protocol was distributed to 9 Stryker branches/agencies in NJ, MD, IN, MI, MN, IL and TX.
  • Product Description
    Hipstar TMZF Cementless Hip Stem Protocol, Product Number: LSP60.
  • 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