Recall Z-1847-2015— Medtronic Navigation, Inc.
Class II · Terminated
Class II FDA medical device recall by Medtronic Navigation, Inc., initiated 2015-05-26, terminated 2015-10-23. FDA's recall record names no specific 510(k) clearance for this event. Product: 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: 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..
- Recalling firm
- Medtronic Navigation, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-05-26
- Terminated
- 2015-10-23
- Firm location
- Louisville, CO, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.