Events

Recall of Stryker Reflex Hybrid Screw Extractor Inner Shaft

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
    54169
  • Event Risk Class
    Class 2
  • Event Number
    Z-0763-2010
  • Event Initiated Date
    2009-10-12
  • Event Date Posted
    2010-04-12
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=87753
  • 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 threaded tip of the reflex hybrid screw extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attempting to remove the screw.
  • Action
    An "Urgent Product Recall" letter was sent to Stryker Branches/Agencies on October 12, 2009 and to surgeons who have used the device on October 26, 2009. The recall letter described the affected products, issue and potential hazards. Consignees were instructed to examine their inventory and hospital locations for the affected products and return to Stryker Spine as indicated in the recall letter. Customers were also instructed to complete the enclosed Customer Response form and fax to 1-201-760-8370. Direct questions about the recall to Stryker Spine by calling 1-201-760-8206.

Device

Stryker Reflex Hybrid Screw Extractor Inner Shaft
  • Model / Serial
    Ref # 48511905B, all lots.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution.
  • Product Description
    Stryker Reflex Hybrid Screw Extractor Inner Shaft; || Not Sterile; || Manufactured by: Stryker Spine SAS, Cestas, France; || Distributed in the US by: Stryker Spine, 2 Pearl Court, Allendale, NJ. || The threaded tip of the Reflex Hybrid Screw Extractor has been found to fracture the head of the screw, causing problems in removing the screw and possible damage to the screw and/or plate while attempting to remove the screw.
  • Manufacturer
    Stryker Spine

Manufacturer

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