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U.S. Department of Health and Human Services

Class 2 Device Recall Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil

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  Class 2 Device Recall Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil see related information
Date Initiated by Firm September 04, 2007
Date Posted November 07, 2007
Recall Status1 Terminated 3 on July 14, 2009
Recall Number Z-0114-2008
Recall Event ID 39409
510(K)Number K930511  
Product Classification electrosurgical pencil - Product Code GEI
Product Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil, sterile, Manufactured at Warsaw, Indiana; REF (P/N) 9560575.
Code Information All lots.
Recalling Firm/
Manufacturer		 Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK
2500 Silveus Crossing
Warsaw IN 46582-8598
For Additional Information Contact
800-876-3133 Ext. 6333
Manufacturer Reason
for Recall		 Packaging weakness may compromise sterility and instructions for use are inadequate.
FDA Determined
Cause 2		 Package design/selection
Action Consignees were notified via letter dated September 4, 2007 to cease using the product and to contact the firm for instructions on how to return the product.
Quantity in Commerce 22,632
Distribution Worldwide, including USA, Hong Kong, India, Mexico, Netherlands, Qatar, Saudi Arabia and South Korea.
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.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = W. J. MEDICAL INSTRUMENTS, INC.
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