—#137215

Product

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 for use in patient registration and palpating brain tissue during surgical procedures.

FDA product code: HAW — Neurological Stereotaxic Instrument
Device class: Class 2
Medical specialty: Neurology
510(k) numbers: K972398
Affected lot / code info: lot number 150223

Why it was recalled

Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip.

Root cause (FDA determination)

Mixed-up of materials/components

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: US Distribution to the states of : CA, MO, LA and PA., and Internationally to Ireland.

Timeline

Recall initiated: 2015-05-05
Posted by FDA: 2015-06-12
Terminated: 2015-07-02
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #137215. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.