Events

Recall of Device Recall Synthes Matrix 5.5.mm Left and Right Coronal Bender

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
    66416
  • Event Risk Class
    Class 2
  • Event Number
    Z-0391-2014
  • Event Initiated Date
    2013-06-22
  • Event Date Posted
    2013-11-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-09-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122360
  • 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
    Instrument, bending or contouring - Product Code HXP
  • Reason
    A complaint was received of the tips of the matrix 5.5.Mm left and right coronal bender breaking while bending a spinal rod component of the matrix system.
  • Action
    Synthes sent an Urgent Notice: Medical Device Recall letter dated June 22, 2013 to users and sales reps. The letter identified the affected product, problem and actions to be taken. For questions call 610-719-5450.

Device

Device Recall Synthes Matrix 5.5.mm Left and Right Coronal Bender
  • Model / Serial
    Parts 03.632.040 and 03.632.041 with various lot nos.  Item Lot Number Number   03.632.040 T935338 03.632.040 T939100 03.632.040 T945062 03.632.040 T953982 03.632.040 T956310 03.632.040 T959990 03.632.040 T959995     Item Lot Number Number   03.632.041 T935343 03.632.041 T939105 03.632.041 T939755 03.632.041 T945067 03.632.041 T952750 03.632.041 T956315 03.632.041 T960000 03.632.041 T960005
  • Product Classification
    Orthopedic Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) including GA, FL, CA, UT, IA, AZ, OH and Internationally to Canada.
  • Product Description
    Synthes Matrix 5.5.mm Left and Right Coronal Bender || Product Usage: The Matrix 5.5.mm Left and Right Coronal Bender are used together to bend the 5.5 Matrix Rods in the coronal plane, and is intended for stabilization of the thoracic, lumbar, sacral, and/or iliac spine through screw and/or hook and rod fixation.
  • 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