Recall Z-0947-2009 ยท ETN Stimulator, Nerve
Medtronic Xomed, Inc.
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.
| Date | Mar 3, 2009 (initiated Nov 21, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | 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 |
| Quantity | 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) |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K031003 | STIMULUS/DISSECTION INSTRUMENTS, BALL-TIP PROBES Medtronic Xomed, Inc., Apr 11, 2003 |