—#97818

Product

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.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K990214
Affected lot / code info: Lot Number 071219

Why it was recalled

Distal end of tactile probe may break off during use.

Root cause (FDA determination)

Labeling design

Action the firm took

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.

Recalling firm

Firm: Medtronic Navigation, Inc
Address: 826 Coal Creek Circle, Louisville, Colorado 80027-9710

Distribution

Distribution pattern: Worldwide Distribution: Nationwide distribution including the states of CO and WI; and the country of South Korea

Timeline

Recall initiated: 2011-01-20
Posted by FDA: 2011-10-03
Terminated: 2011-10-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #97818. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.