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.
- Company
- Medtronic Xomed, Inc.
- Recall Initiated
- November 21, 2008
- Posted
- March 3, 2009
- Terminated
- October 1, 2009
- Recall Number
- Z-0947-2009
- Quantity
- 22 boxes (220 units)
- Firm Location
- Jacksonville, FL
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.
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)
Lot / Code Info
Lot Number 58536200.
Root Cause
Employee error
Action Taken
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.