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U.S. Department of Health and Human Services

Class 2 Device Recall Sarns Sternal Saw II System Power Unit

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  Class 2 Device Recall Sarns Sternal Saw II System Power Unit see related information
Date Initiated by Firm February 14, 2008
Date Posted December 02, 2008
Recall Status1 Terminated 3 on July 07, 2009
Recall Number Z-0358-2009
Recall Event ID 46313
Product Classification Sternal Saw Power Unit - Product Code GFA
Product Terumo Sarns Sternal Saw II System Power Unit, 115 V, Terumo Cardiovascular Systems Corp., Ann Arbor, MI; Catalog # 15670.

Indicated for use in medial sternotomies. The Sarns Sternal Saw II system consists of a disposable blade, saw, flexible drive shaft, motor and foot control.
Code Information Serial numbers 5866 through 5887.
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Road
Ann Arbor MI 48103-9586
For Additional Information Contact
800-521-2818
Manufacturer Reason
for Recall		 The drive power cable cannot be fully inserted into the power unit or can only be inserted with difficulty, resulting in the device not being operational.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Consignees were notified via Urgent Medical Device Removal letter dated 2/14/08 to not use the device if it exhibited the problem, provided a response card, and stated that replacement motors will be shipped to the person listed on the returned response card.
Quantity in Commerce 69 total
Distribution Worldwide Distribution --- including USA and countries of Belgium, China, Columbia, Malaysia, Philippines, United Arab Emirates, and Venezuela.
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.
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