Events

Recall of Device Recall Sarns Sternal Saw I System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Terumo Cardiovascular Systems Corporation.

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
    60011
  • Event Risk Class
    Class 2
  • Event Number
    Z-0978-2012
  • Event Initiated Date
    2011-11-17
  • Event Date Posted
    2012-02-07
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-12-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104231
  • 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
    Blade, saw, surgical, cardiovascular - Product Code DWH
  • Reason
    Terumo cardiovascular systems has received one report of minute metal shavings leaking from the sarns sternal saw i system at the point where the saw blade is inserted into the saw handpiece.
  • Action
    On 11/16/2011, 11/23/11, 02/3/12, 03/22/12, and 4/24/12 the firm sent a letter entitled "URGENT MEDICAL DEVICE RECALL" to it's domestic direct accounts that included the name of the device, catalog and lot numbers, dates of distribution, and instructions to discontinue use and return the device to the firm for destruction, with a Fax-back response form to be submitted. Medwatch reporting information was also included in the letter. Questions and comments are to be addressed by Customer Service @ 1-800-521-2818, M-F, 8-6 EST

Device

Device Recall Sarns Sternal Saw I System
  • Model / Serial
    Catalog number 6090, Serial Numbers 0 - 10186
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA, and the countries of Colombia, Argentina, Lebanon, Belgium, Chile, India, Sri Lanka, Jordan, Egypt, Mexico, Brazil, Taiwan, Honduras, Canada, Germany, Singapore, Republic of Georgia, Hong Kong, Japan, UAE, Philippines, Thailand and South Africa.
  • Product Description
    Terumo, Sarns Sternal Saw I System, Catalog 6090. The Sarns Sternal Saw I is indicated for use in splitting the sternum during thoracic surgery.
  • Manufacturer
    Terumo Cardiovascular Systems Corporation

Manufacturer

Terumo Cardiovascular Systems Corporation
  • Manufacturer Address
    Terumo Cardiovascular Systems Corporation, 6200 Jackson Road, Ann Arbor MI 48103-9586
  • Manufacturer Parent Company (2017)
    Terumo Corp.
  • Source
    USFDA