Events

Recall of Synthes TomoFix Plates

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
    Recall
  • Event ID
    66582
  • Event Risk Class
    Class 2
  • Event Number
    Z-0473-2014
  • Event Initiated Date
    2013-10-09
  • Event Date Posted
    2013-12-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-12-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122651
  • 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, multiple component - Product Code KTT
  • Reason
    A labeling correction was initiated related to the surgical technique guide j5606-c "tomofix osteotomy system" due to the potential for a surgical delay if the surgeon inserts the superior screws at a lesser angle (4 or 6 degrees) and is not aware that those angles are not present.
  • Action
    Synthes sent an Urgent Field Safety Notification/Medical Device Labeling Correction letter dated October 9, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to exchange the old surgical technique guide version J5606-C with the new version J5606-D provided with this notification. Review the revised surgical technique guide (Pages 25 & 26). Forward this Field Safety Notification to anyone in their facility that need to be informed. If the surgical technique guide has been forwarded to another facility, contact that facility. Maintain awareness of this notice until all surgical technique guides have been exchanged. Maintain a copy of this notice. Customers with questions were instructed to contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.

Device

Synthes TomoFix Plates
  • Model / Serial
    J5606-C
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - USA (nationwide) Canada and Mexico
  • Product Description
    Synthes TomoFix Plates || The Synthes J5606-C TomoFix Osteotomy System is used for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.
  • Manufacturer
    Synthes USA HQ, Inc.

Manufacturer

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