Recall Z-1598-2014 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc.
TRAJ GUIDE KIT, 9733066, BIOPSY, INT
| Date | May 9, 2014 (initiated Apr 24, 2014) |
| Status | Terminated |
| Reason | 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 | Nonconforming Material/Component |
| Action | 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. |
| Quantity | 26,674 total |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001284 | STEALTHSTATION SYSTEM GOLDENEYE MICRO-MAGNETIC TRACKING SYSTEM Medtronic Surgical Navigation Technologies, Jun 12, 2000 |
| K012937 | KNEE MODULE FOR THE STEALTHSTATION SYSTEM Medtronic Surgical Navigation Technologies, Jan 25, 2002 |
| K022074 | SPHERZ I.Z.I. Corp., Aug 13, 2002 |
| K033621 | NDI PASSIVE SPHERES Northern Digital, Inc., Jan 27, 2004 |
| K871247 | KRONNER UNIVERSAL FRAME EXTERNAL FIXATION Kronner Medical, May 22, 1987 |
| K990214 | FLUORONAV MODULE FOR THE STEALTHSTATION SYSTEM Surgical Navigation Technologies, Inc., Apr 22, 1999 |