Events

Recall of Lateral Decubitus Alignment Guide

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
    52375
  • Event Risk Class
    Class 2
  • Event Number
    Z-1817-2009
  • Event Initiated Date
    2006-04-27
  • Event Date Posted
    2009-08-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=82807
  • 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
    Impactor - Product Code HWA
  • Reason
    The lateral decubitus alignment guide either did not assemble to its mating part, the curved impaction handle, or partially engages the handle, but does not fully lock.
  • Action
    Important Market Withdrawal Letters were sent to Stryker Branches on April 27, 2006 vis Federal Express. The letter asked consignees to examine their inventory and identify the product. They are to retrieve all affected product lots and return to their branch or agency warehouse for reconciliation. Also, they are to reconcile all product on the attached Product Accountability Form and fax a copy. Affected should be returned and their Stryker Orthopaedics Customer Service Rep should be contacted to re-order the product that is being returned as part of this recall. Questions should be referred to Rita Intorella at 201-831-5825.

Device

Lateral Decubitus Alignment Guide
  • Model / Serial
    Lot codes: TACFA03, TACFA0G, TACFA0M, TACF12P, & TACG104.
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution
  • Product Description
    Lateral Decubitus Alignment Guide, Non Sterile; manual surgical instrument. The MIS Hip Acetabular instrument set includes the curved positioner/impactor, supine alignment guide, and decubitus alignment guide. || Catalog No. 1440-1370 || Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. || Authorized Representative in Europe: Stryker France, Cedex France. || The correct position of the cup relative to the pelvic reference planes can be achieved by the use of the alignment guide.
  • 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