PlainRecalls
FDA Devices Moderate Class II Terminated

Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set configuration varies dependent on the part number. The devices are assembled and packaged into a shipping carton or into a holding tray which is then placed into a shipping carton. Designed for use in spine surgery to assist in the tapping procedure and the placement of screws during the surg

Reported: July 8, 2015 Initiated: May 26, 2015 #Z-1847-2015

Product Description

Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set configuration varies dependent on the part number. The devices are assembled and packaged into a shipping carton or into a holding tray which is then placed into a shipping carton. Designed for use in spine surgery to assist in the tapping procedure and the placement of screws during the surgery.

Reason for Recall

Medtronic Navigation is initiating a field correction due to the potential for injury which could occur as a result of cleaning the Medtronic Navigated Cannulated Taps.

Details

Units Affected
15,798
Distribution
Worldwide Distribution.
Location
Louisville, CO

Frequently Asked Questions

What product was recalled?
Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective plastic end caps. Kit/sets contain various devices including the taps. The kit/set configuration varies dependent on the part number. The devices are assembled and packaged into a shipping carton or into a holding tray which is then placed into a shipping carton. Designed for use in spine surgery to assist in the tapping procedure and the placement of screws during the surgery.. Recalled by Medtronic Navigation, Inc.. Units affected: 15,798.
Why was this product recalled?
Medtronic Navigation is initiating a field correction due to the potential for injury which could occur as a result of cleaning the Medtronic Navigated Cannulated Taps.
Which agency issued this recall?
This recall was issued by the FDA Devices on July 8, 2015. Severity: Moderate. Recall number: Z-1847-2015.