Recall of Synthes Spiral Blade Component of the Synthes Modular Blade Plate System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Synthes USA (HQ), Inc..

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, nail/blade/plate combination - Product Code KTW
  • Reason
    Potential for out of specification star grind teeth.
  • Action
    Synthes initiated their recall on October 18, 2010, notifying affected hospital accounts via consultant communication. Affected Synthes Trauma Sales Consultants were notified via email (receipt requested). A copy of the Urgent Medical Device Recall letter dated October 20, 2010, was mailed via UPS second day air on October 20, 2010. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to identify any affected devices and call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. A replacement order would be taken at that time. Customers were also instructed to complete the Verification Section at the end of the letter by checking the appropriate box indicating the affected product had been located or indicating in the appropriate box that no affected product was located. Also, customers were to indicate the number of devices found and note the Return Authorization Number. Return the Verification Form with the recalled product to: Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. For questions regarding this recall call 1-800-620-7025, x 6883.


  • Model / Serial
    All lots of Part Number: 02.122.605S, 105mm Spiral Blade, 14mm, Right-Sterile
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    Nationwide Distribution including AL, CA, GA, IA, IL, IN, MA, MI, MS, NC, NJ, NV, OH, PA, SC, SD, TN, and WV.
  • Product Description
    02.122.605S, 105mm Spiral Blade, 14mm, || Right-Sterile - Synthes Spiral Blade Component of the Synthes Modular Blade Plate System || For fixation of fractures and osteotomies of the proximal and distal femur in adolescents and adults.
  • Manufacturer


  • Manufacturer Address
    Synthes USA (HQ), Inc., 1302 Wrights Ln E, West Chester PA 19380-3417
  • Manufacturer Parent Company (2017)
  • Source