Medtronic Navigation, Inc. recalls Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174,…

Recall date

May 5, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1794-2015

FDA classification

Class II

Brand / firm

Medtronic Navigation, Inc.

Sold / distributed

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

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.