Recall of Device Recall Stryker Reflex Hybrid Variable SelfTapping Screw

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
  • Event ID
  • Event Risk Class
    Class 2
  • Event Number
  • Event Initiated Date
  • Event Date Posted
  • Event Status
  • Event Country
  • Event Terminated Date
  • Event Source
  • Event Source URL
  • 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
    Design flaw: the design did not prevent over angulation of the screws when the recommended instrument, all in one guide, was not used.
  • Action
    Stryker Spine issued an "Important Market Withdrawal" notice dated June 14, 2006. Consignees were advised to complete and return a Product Accountability Form via fax to 1-201-831-6069 prior to returning the affected product. Product return was to be performed during certain phase periods when upgrades were being shipped. For further questions, contact Stryker Spine at 1-201-831-5825.


  • Model / Serial
    All Product with the following Catalog Number/Description: 48684012, Variable Angle Bone Screw, diameter 4.0 x 10 mm; 48684012, diameter 4.0 x 12 mm; 48684014, diameter 4.0 x 14 mm; 48684018, diameter 4.0 x 18 mm; 48684020, diameter 4.0 x 20 mm; 48684512, diameter 4.5 x 12 mm; 48684516, diameter 4.5 x 14 mm; 48684516, diameter 4.5 x 16 mm; 48684518, diameter 4.5 x 18 mm; 48684520, diamter 4.5 x 20 mm.
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide Distribution -- Including states of NC, OR, AZ, TN, CA, MA, MD, IL, GA, FL, NJ, NM, KY, LA, PA, MI, UT, MO, OK, KS, OH, MN, NE, IN, MT, TX, AL, CO and WI.
  • Product Description
    Stryker Reflex Hybrid Variable Self-Tapping Screw. || Non Sterile. Manufactured by Stryker Spine, SAS, Cestas, France. Distributed in USA by Howmedica Osteonics, Mahwah, NJ 07430.
  • Manufacturer


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