Medtronic Sofamor Danek USA Inc recalls Medtronic ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only

Recall date

December 22, 2017

Source

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

Recall number

Z-0566-2018

FDA classification

Class II

Brand / firm

Medtronic Sofamor Danek USA Inc

Sold / distributed

MN, NC

Why it was recalled

Medtronic has discovered the product lot in question was noted as having a longer drill tip extension than what is indicated on the print specification.

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 ANGLED DRILL, REF 6630902, QTY: 1 EA Rx only