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.
Recall
- Recall Number
- Z-0947-2009
- Event Number
- 50736
- Firm
- Medtronic Xomed, Inc.
- FEI Number
- 1045254
- Product Code
- ETN
- Status
- Terminated
- Root Cause
- Employee error
- Initiated
- November 21, 2008
- Posted
- March 3, 2009
- Terminated
- October 1, 2009
- Address
- 6743 Southpoint Dr N, Jacksonville, FL, 32216-6218
Description
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.
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.
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.
Worldwide Distribution --- including USA and country of Canada. (22 boxes were distributed within U.S. Three boxes were distributed to Medtronic Canada but returned)
22 boxes (220 units)