—#127010

Product

INSTRUMENT TRACKER 9733533XOM ENT 1PK

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K001284, K012937, K022074, K033621, K871247, K990214
Affected lot / code info: Lot No.: 130904C 131203A 131003 131024B 130815 130904C 130510 130815 130708B 130815 130815 130716D 130204C 130418B 121128C 121218B 121218A 121128D 130409C 130409D 130123

Why it was recalled

Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Domestic Urgent Medical Device Safety Notice letters were shipped on April 24 and 25, 2014. The letters indicated that a Medtronic representative will contact the hospital and arrange for a visit to collect affected products and arrange for no charge replacements or credit. Questions regarding this recall should be directed to Medtronic Navigation Technical Services at 1-800-595-9709.

Recalling firm

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

Distribution

Distribution pattern: Nationwide Distribution

Timeline

Recall initiated: 2014-04-24
Posted by FDA: 2014-05-09
Terminated: 2014-12-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #127010. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.