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 Recall Z-0002-2012 · Posted 2011-10-03
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Recalling FirmMedtronic Navigation, Inc
Recall StatusTerminated
Product CodeHAW
Date Initiated2011-01-20
Date Terminated2011-10-03
Product Quantity6 probes
Reason for Recall
Distal end of tactile probe may break off during use.
Firm 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.
Root Cause
Labeling design
Distribution Pattern
Worldwide Distribution: Nationwide distribution including the states of CO and WI; and the country of South Korea
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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