—#127020

Product

SPHERES 8801075 5/TRAY 12PK

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.: 1207251 1301091 1301081 1211141 1301151 1302051 1303141 1303121 1303191 1304031 1304081 1303071 1305221 1305281 1306181 1306231 1307041 1307051 1307111 1307131 1307121

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 #127020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.