Events

Recall of Stryker TRIO/TRIO

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Stryker Spine.

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
    62663
  • Event Risk Class
    Class 2
  • Event Number
    Z-2235-2012
  • Event Initiated Date
    2012-04-25
  • Event Date Posted
    2012-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-02-27
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=111305
  • 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, spinal pedicle fixation - Product Code MNI
  • Reason
    The front cover of instructions for use (ifu) #noli135b03rev02 was improperly marked with a "sterile" logo in the lower right corner. the products these ifus were packed with are sold as "non-sterile" and require sterilization before use in surgery.
  • Action
    Stryker sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter to affected customers. The letter identifies the product, problem, and actions to be taken by the customers. A Customer Response Form was attached for customers to complete and return via fax to 201-760-8370. Contact the firm at 201-760-8298 for questions regarding this notice.

Device

Stryker TRIO/TRIO
  • Model / Serial
    Code information listed in the following format: Manufacturer Part Number/Prodcut Description/Corresponding IFU Part Number/Affected Lot #s are as follows:  48900445/Trio Standard Post Screw 5.5x55mm/#NOLI135B03Rev02/57281 and 57201  48900450/Trio Standard Post Screw 5.5x60mm/#NOLI135B03Rev02/57197   48900455/Trio Standard Post Screw 4.5x45mm/#NOLI135B03Rev02/57198  48900555/Trio Standard Post Screw 4.5x50mm/#NOLI135B03Rev02/56599  48900560/Trio Standard Post Screw 4.5x55mm/#NOLI135B03Rev02/57192
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in Atlanta, Georgia.
  • Product Description
    The Instructions For Use for the following: || Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW || Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW || Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW || Stryker TRIO+ 5.5 x 45 mm STANDARD POST SCREW || Stryker TRIO+ 5.5 x 60 mm STANDARD POST SCREW || Manufactured by: STRYKER Spine SAS, Z.I. Marticot - 33610 - Cestas-France +33 (0)5.57.97.06.30 http://www.stryker.com || Distributed in the USA by: Stryker Spine, 2 Pearl Ct., Allendale, NJ 07401-1677 USA +1-201-750-8000. || The system is intended for posterior, non-cervical pedicle and non-pedicle pedicle fixation of the spine. It is indicated for: degenerative disc disease (DDD), spondylolisthesis, fracture, dislocation, spinal stenosis, scoliosis kyphosis, lordosis, spinal tumor, pseudarthrosis, and failed previous fusion.
  • Manufacturer
    Stryker Spine

Manufacturer

Stryker Spine
  • Manufacturer Address
    Stryker Spine, 2 Pearl Ct, Allendale NJ 07401-1611
  • Manufacturer Parent Company (2017)
    Stryker
  • Source
    USFDA