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U.S. Department of Health and Human Services

Class 2 Device Recall STIMULUS/DISSECTION INSTRUMENTS, BALLTIP PROBES

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  Class 2 Device Recall STIMULUS/DISSECTION INSTRUMENTS, BALLTIP PROBES see related information
Date Initiated by Firm November 21, 2008
Date Posted March 03, 2009
Recall Status1 Terminated 3 on October 01, 2009
Recall Number Z-0947-2009
Recall Event ID 50736
510(K)Number K031003  
Product Classification Stimulator, nerve - Product Code ETN
Product VARI-STIM III Nerve Locator/Stimulator, Sterile, Medtronic Xomed, Inc.

The Vari-Stim III nerve locator/stimulator is a sterile, single-use disposable, hand-held, battery-operated device intended to stimulate motor nerves exposed during surgery for the purpose of identification or location.
Code Information Lot Number 58536200.
Recalling Firm/
Manufacturer		 Medtronic Xomed, Inc.
6743 Southpoint Dr N
Jacksonville FL 32216-6218
For Additional Information Contact
904-296-9600
Manufacturer Reason
for Recall		 Device may fail to operate or operate intermittently during use and such operation could result in a lack of nerve stimulation when nerve tissue is actually contacted by the stimulator.
FDA Determined
Cause 2		 Employee error
Action All consignees were contacted by telephone (initiated on November 10, 2008). After telephone contact, each consignee was sent a follow-up fax/letter, "Urgent Product Recall Notification". The letter described the issue and actions for customers to take in response to the recall. Customers were instructed to check their inventories and return affected product to Medtronic Xomed, Inc. Customers were also instructed to fax their completed "Customer Contact and Product Return Checklist" to Medtronic Xomed, Inc. at 1-904-296-2386. Direct questions to Medtronic ENT Customer Service at 1-800-874-5797 (select Option 1 for Customer Service) and ask for the Vari-Stim Field Action Contact Person.
Quantity in Commerce 22 boxes (220 units)
Distribution Worldwide Distribution --- including USA and country of Canada. (22 boxes were distributed within U.S. Three boxes were distributed to Medtronic Canada but returned)
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 = ETN and Original Applicant = MEDTRONIC XOMED, INC.
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