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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 Recall
Medtronic Sofamor Danek METRx (TM) System Bayonet Electrosurgical Pencil
see related information
Date Posted November 07, 2007
Recall Status1 Terminated on July 14, 2009
Recall Number Z-0114-2008
Recall Event ID 39409
Premarket Notification
510(K) Number
K930511 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - 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, Indiana 46582-8598
Manufacturer Reason
for Recall
Packaging weakness may compromise sterility and instructions for use are inadequate.
FDA Determined
Cause 2
DESIGN: Packaging 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = W. J. MEDICAL INSTRUMENTS, INC.
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