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U.S. Department of Health and Human Services

Class 1 Device Recall Smith & Nephew

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  Class 1 Device Recall Smith & Nephew see related information
Date Initiated by Firm January 19, 2007
Date Posted March 29, 2007
Recall Status1 Terminated 3 on January 18, 2008
Recall Number Z-0663-2007
Recall Event ID 37232
510(K)Number K034012  
Product Classification Probe, Radiofrequency Lesion - Product Code GXI
Product RF Denervation Probe, 10 cm, temperature sensing electrodes designed for use in radiofrequency lesion procedures for the treatment of pain.
Product Number: 7210271
Code Information Lot Numbers: 602541, 602542, 602556, 602557, 602558, 602559, 602560, 602561, 602562, 602848, 602849, 602999
Recalling Firm/
Manufacturer
Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
For Additional Information Contact Jason Bilobram
978-474-6332
Manufacturer Reason
for Recall
Product is non-sterile but labeled incorrectly as sterile.
FDA Determined
Cause 2
Other
Action Smith & Nephew notified accounts by letter sent via Federal Express January 19, 2007
Quantity in Commerce 338 units
Distribution Worldwide, including USA, Denmark, France, UK, Germany, Korea, Switzerland, Italy, Spain, 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.
510(K) Database 510(K)s with Product Code = GXI and Original Applicant = SMITH & NEPHEW, INC.
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