Recall Z-0002-2012 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc
Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instruments used in spine surgeries for preparation of the pedicle. These instruments are used in conjunction with the Medtronic Navigation StealthStation platform and various software applications.
| Date | Oct 3, 2011 (initiated Jan 20, 2011) |
| Status | Terminated |
| Reason | Distal end of tactile probe may break off during use. |
| Root cause | Labeling design |
| Action | Medtronic sent an "Urgent Product Safety Notice" to all affected customers dated Jan 20, 2011. The letter included affected product and updated instructions for use. On-site training was given for the use of the probes by Medtronic Representatives. For information on this recall call Medtronics at (720) 890-3409. |
| Quantity | 6 probes |
| Distribution | Worldwide Distribution: Nationwide distribution including the states of CO and WI; and the country of South Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990214 | FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM Surgical Navigation Technologies, Inc., Apr 22, 1999 |