Events

Recall of STRYKER SPINE TRIO SPINAL FIXATION SYSTEM

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
    50753
  • Event Risk Class
    Class 2
  • Event Number
    Z-0986-2009
  • Event Initiated Date
    2006-09-05
  • Event Date Posted
    2009-04-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-04-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76978
  • 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
    Reports were received of the ball ring ejecting from the connector's body when other connectors have already been locked down.
  • Action
    A notification letter dated September 12, 2006 and a Product Accountability Form were sent via Federal Express (with return receipt) to all affected branches/agencies. Further information can be found by calling 1-201-760-8256.

Device

STRYKER SPINE TRIO SPINAL FIXATION SYSTEM
  • Model / Serial
    Catalog Number 48902015; Lot codes: 056254, 056255, 056256, 056257, 56258, 056259, 058065, 05A140, 05A142, 058066, 05A139, 05A141, 058915, 05A143, 05A145, 05A146, 05A144, 061075, 061077, 061551, 061072, 061076, 0615550, 061549, 061760, 05A148, 05A149, and 05A147.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution including OR, CA, MA, VA, GA, FL, NY, NM, NJ, UT, KS, OH, MI, MN, IN, MT, TX, WI, AL, CO, and TN.
  • Product Description
    Stryker Trio Small Offset Connector || Non Sterile; Manufactured by Stryker Spine SAS, Z.I. Marticot -33610- Cestas, France. Distributed in USA by Howmedica Osteonics Corp., Mahwah, NJ. || The Trio Spinal Fixation Systems are pedicle screws systems intended for use in providing immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic lumbar, and sacral spine: degenerative spondyolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor 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