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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns Sternal Saw I System

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  Class 2 Device Recall Sarns Sternal Saw I System see related information
Date Initiated by Firm November 17, 2011
Date Posted February 07, 2012
Recall Status1 Terminated 3 on December 06, 2012
Recall Number Z-0978-2012
Recall Event ID 60011
Product Classification Blade, saw, surgical, cardiovascular - Product Code DWH
Product Terumo, 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/
Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact Terumo Cardiovascular Customer Service
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
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
Quantity in Commerce approx. 10186
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.
Total Product Life Cycle TPLC 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.