Recall Z-1794-2015 ยท HAW Neurological Stereotaxic Instrument
Medtronic Navigation, Inc.
Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174, 9733935. As part of kits, the product is either packaged with other instruments or into a holding tray. The Passive Planar Blunt Probe is an optically tracked, reusable instrument used in navigated surgery and is included with Medtronic cranial instrument kits. It is designed fo
| Date | Jun 12, 2015 (initiated May 5, 2015) |
| Status | Terminated |
| Reason | Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip. |
| Root cause | Mixed-up of materials/components |
| Action | Medtronic sent an Medical Device Safety Alert letter dated May 5, 2015, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action to be taken by the user: "Examine your inventory and if any of the affected products are found, please quarantine them for return to Medtronic. "A Medtronic representative will follow-up to arrange for removal and replacement. If you have any questions regarding this action, please contact Medtronic Navigation Technical Services at 1-800-595-9709. |
| Quantity | 18 |
| Distribution | US Distribution to the states of : CA, MO, LA and PA., and Internationally to Ireland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K972398 | STEALTHSTATION PASSIVE INSTRUMENT OPTION Surgical Navigation Technologies, Inc., Sep 16, 1997 |