FDA Device Recall Z-0002-2012: Medtronic Navigation, Inc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0002-2012.

Recall Res Number

Z-0002-2012

Recalling Firm / Manufacturer

Medtronic Navigation, Inc

FEI Number

1000517638

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2011-01-20

Date Posted

2011-10-03

Date Terminated

2011-10-03

Product Code

HAW

Event Number

57858

Product Quantity

6 probes

Product Description 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.

Reason for Recall Distal end of tactile probe may break off during use.

Action Details 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.

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

Code Information / Serial Numbers Lot Number 071219

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Medical Device Recall: Z-0002-2012

Recall Parameters & Description

Related Establishments / Registrations

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