FDA Enforcement
Class II
Terminated
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.
Recall: Z-1794-2015
·
Reported June 24, 2015
Enforcement
- Recall Number
- Z-1794-2015
- Event ID
- 71278
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Medtronic Navigation, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 24, 2015
- Initiation Date
- May 5, 2015
- Classification Date
- June 12, 2015
- Termination Date
- July 2, 2015
- Address
- 826 Coal Creek Cir, Louisville, CO, 80027-9710, United States
Description
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.
Reason
Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip.
Code Info
lot number 150223
Distribution
US Distribution to the states of : CA, MO, LA and PA., and Internationally to Ireland.
Quantity
18