Probe, Tactile, Right, ASM, Long, Part #962011S, Medtronic Navigation, Louisville, CO 80027. Trackable hand held instrum
FDA device recall Z-0002-2012 · posted 2011-10-03 · Terminated
Recall details
- Recalling firm
- Medtronic Navigation, Inc
- Reason for recall
- Distal end of tactile probe may break off during use.
- Action taken
- 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
- Status
- Terminated
- Product code
- HAW
- Quantity affected
- 6 probes
- Distribution
- Worldwide Distribution: Nationwide distribution including the states of CO and WI; and the country of South Korea
- Date initiated
- 2011-01-20
- Date posted
- 2011-10-03
- Date terminated
- 2011-10-03
- Location
- Louisville, CO
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