Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Sarns Sternal Saw I System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Sarns Sternal Saw I Systemsee related information
Date Initiated by FirmNovember 17, 2011
Date PostedFebruary 07, 2012
Recall Status1 Terminated 3 on December 06, 2012
Recall NumberZ-0978-2012
Recall Event ID 60011
Product Classification Blade, saw, surgical, cardiovascular - Product Code DWH
ProductTerumo, Sarns Sternal Saw I System, Catalog 6090. The Sarns Sternal Saw I is indicated for use in splitting the sternum during thoracic surgery.
Code Information Catalog number 6090, Serial Numbers 0 - 10186
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information ContactTerumo Cardiovascular Customer Service
734-741-6173
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Equipment maintenance
ActionOn 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
Quantity in Commerceapprox. 10186
DistributionWorldwide 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-