Events

Recall of The TRIO Spondylolisthesis Reduction Instrument is a Class I Manual Surgical Instrument unique to the implantation of Stryker Spine TRIO PS this instrument is intended for use in the reduction of degenerative Spondylolisthesis.

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
    32212
  • Event Risk Class
    Class 2
  • Event Number
    Z-1554-05
  • Event Initiated Date
    2005-05-16
  • Event Date Posted
    2005-09-21
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2005-12-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=39387
  • 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
    Orthosis, Spondylolisthesis Spinal Fixation - Product Code MNH
  • Reason
    The threaded part of the instrument may break when connected to the screw and potentially result in an adverse health consequence.
  • Action
    The notification letters and product accountability forms were sent to their branches/agencies and the one hospital via Fedex on 5/16/2005 with return receipt.

Device

The TRIO Spondylolisthesis Reduction Instrument is a Class I Manual Surgical Instrument unique to...
  • Model / Serial
    Catalog No: 48905110 Lot Code: 039524; 039981; 045152; 045153; 045154; 045155; 045156; 045157; 045158; 045159; 048721; 048722.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Stryker distributes their product though branches/agencies and occassionally directly to hospitals. These branches/agencies are located nationwide and will deliver the device to the medical facility. There are 31 branches and 1 hospital involved.
  • Product Description
    The TRIO Spondylolisthesis Reduction Instrument is a Class I Manual Surgical Instrument unique to the implantation of Stryker Spine TRIO PS this instrument is intended for use in the reduction of degenerative Spondylolisthesis.
  • 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