Recalls / —
—#127012
Product
MOUSE 9732721 STERILE O-ARM 10PK
- FDA product code
- GXY — Electrode, Cutaneous
- Device class
- Class 2
- Medical specialty
- Neurology
- 510(k) numbers
- K001284, K012937, K022074, K033621, K871247, K990214
- Affected lot / code info
- Lot No.: 5051140611 5336060213 5162060112 4734921009
Why it was recalled
Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
Root cause (FDA determination)
Nonconforming Material/Component
Action the firm took
Domestic Urgent Medical Device Safety Notice letters were shipped on April 24 and 25, 2014. The letters indicated that a Medtronic representative will contact the hospital and arrange for a visit to collect affected products and arrange for no charge replacements or credit. Questions regarding this recall should be directed to Medtronic Navigation Technical Services at 1-800-595-9709.
Recalling firm
- Firm
- Medtronic Navigation, Inc.
- Address
- 826 Coal Creek Cir, Louisville, Colorado 80027-9710
Distribution
- Distribution pattern
- Nationwide Distribution
Timeline
- Recall initiated
- 2014-04-24
- Posted by FDA
- 2014-05-09
- Terminated
- 2014-12-29
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #127012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.