Orthofix, Inc recalls ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various d…

Recall date

May 11, 2015

Source

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

Recall number

Z-1819-2015

FDA classification

Class II

Brand / firm

Orthofix, Inc

Sold / distributed

Nationwide Distribution including CA, VA, FL, ID, CO, OR, PA, OK, SC, and TX.

Why it was recalled

There is a possibility that the thumb button remains in the depressed (unlocked) position allowing the threaded sleeve (drill stop) to unintentionally rotate and change the depth setting.

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

What was recalled

ORTHOFIX Centurion POCT System Drill Guide PN 69-1010 and PN 69-1012. Drill Guides are used to interface with various drill tips during the drilling procedure of bone preparation.