Events

Recall of Device Recall Holding Forceps for Trident Acetabular System

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
    52384
  • Event Risk Class
    Class 3
  • Event Number
    Z-0539-2010
  • Event Initiated Date
    2007-01-24
  • Event Date Posted
    2009-12-16
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-12-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82817
  • 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
    Forceps - Product Code HTD
  • Reason
    The tips of the forceps were larger than the positioning holes located on the trials and the implant liners.
  • Action
    Important Product Correction letters, dated January 24, 2007, were sent to all consignees on via Federal Express. The letter stated the problem and asked customers to examine their inventory and hospital locations to identify the affected product. All affected forceps product should be retrieved from hospitals and returned to their branch or agency warehouse for reconciliation. Customers are also to reconcile all affected product on the attached Product Accountability Form and fax a copy of that form to 201-831-6069 within 5 days of receipt of the letter. All affected forceps product is to be destroyed and discarded at their branch location. Questions should be directed to their Stryker Orthopaedics Customer Service rep at 1-866-OR-ASSIST.

Device

Device Recall Holding Forceps for Trident Acetabular System
  • Model / Serial
    All lots beginning with V1 (XXX).
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution -- Including countries of Hong Kong, Australia, Japan, New Zealand, Hong Kong, Singapore, Germany, Sweden, The Netherlands, France, Spain, Portugal, and the United Kingdom.
  • Product Description
    Holding Forceps for Trident Acetabular System; non Sterile; || Catalog number 2105-0000; || Howmedica Osteonics Corp, 325 Corporate Drive, || Mahwah, NJ 07430; || Authorized representative in Europe: || Stryker France, Cedex. France || The Holding Forceps for Acetabular trial cups help facilitate the insertion / correction of the Acetabular trial inserts.
  • Manufacturer
    Stryker Howmedica Osteonics Corp.

Manufacturer

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