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 Recall Z-1794-2015 · Posted 2015-06-12
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Recalling FirmMedtronic Navigation, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2015-05-05
Date Terminated2015-07-02
Product Quantity18
Reason for Recall
Passive Planar Blunt Probe (Lot# 150223) was manufactured with a sharp tip rather than a blunt tip.
Firm 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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
US Distribution to the states of : CA, MO, LA and PA., and Internationally to Ireland.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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