Medtronic Navigation, Inc. recalls Medtronic Navigated Cannulated Taps Individual cannulated taps are packaged in a clear plastic tube with protective pla…

Recall date

May 26, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1847-2015

FDA classification

Class II

Brand / firm

Medtronic Navigation, Inc.

Sold / distributed

Worldwide Distribution.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What 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.