Events

Recall of REFLEX HYBRID ANTERIOR CERVICAL PLATE 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
    49441
  • Event Risk Class
    Class 3
  • Event Number
    Z-0217-2009
  • Event Initiated Date
    2008-08-18
  • Event Date Posted
    2008-11-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-06-19
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73332
  • 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
    Appliance, fixation, spinal intervertebral body. - Product Code KWQ
  • Reason
    The reflex hybrid 4.0 x 14 mm variable, self tapping bone screw, lot nsz, was determined to have been anodized with the incorrect color for that screw.
  • Action
    An URGENT Product Recall Letter and a Stryker Spine Accountability Form were sent via FedEx with return receipt on August 18, 2008 to Stryker Branches and Hospital OR Supervisors. Letters notified branches of the recall and requested that they immediately identify and quarantine affected product and notify hospital locations that received shipment of product within 72 hours prior to identification of the problem. Letters sent to Hospital OR Supervisors described the problem and requested that all inventory locations be checked for affected product. If recalled product is found, Stryker Spine Representatives must be contacted to retrieve the recalled product from the facility. The Stryker Spine Accountability Form must be completed and returned via fax, 201-760-8269 to Stryker Spine. Contact Stryker Spine Clinical and Regulatory Affairs at 201-760-8150 or 201-760-8069 for questions or additional information.

Device

REFLEX HYBRID ANTERIOR CERVICAL PLATE SYSTEM
  • Model / Serial
    Lot code: NSZ.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Nationwide Distribution.
  • Product Description
    Reflex Hybrid 4.0 x 14 mm Variable, Self-Tapping Bone Screw (Non- sterile). || Manufactured by Stryker Spine SAS, Cestas, France. Distributed in USA by Howmedica Osteonics, Mahwah, NJ. || The bone screw (Reference # 48694014) is a 04.0 x 14mm used to attach the Reflex Hybrid Anterior Cervical Plate (ACP) to the anterior surface of the spine. The intended use of the system is as an aid in cervical spinal fusion through unilateral fixation.
  • Manufacturer
    Stryker Spine

Manufacturer

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