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Medtronic Navigation, Inc. recalls Medtronic Passive Planar Blunt Probe Part Number 960-556, also included in Part Number Kits: 9732540, 9732622, 9733174,
Recalled June 24, 2015 · FDA recall Z-1794-2015 · Medtronic Navigation
Hazard
Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip. · FDA Class II
Units
18
Sold at
US Distribution to the states of : CA, MO, LA and PA., and Internationally to Ireland.
Description
Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip.
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.
Manufacturer(s)
Medtronic Navigation, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →