New Standard Device Inc recalls Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill…

Recall date

December 28, 2020

Source

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

Recall number

Z-1649-2022

FDA classification

Class II

Brand / firm

New Standard Device Inc

Sold / distributed

U.S.: AZ, GA, IL MT, NC, NJ, NV, OH, PA, TX, and VA O.U.S.: None

Why it was recalled

Complaints were received for Self-drill Half-Pin tip breakages occurring during surgery.

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

What was recalled

Metalogix Self-Drill Half-Pin, a component of the Revolution External Fixation System. Orthopedic. Metalogix Self-Drill Half-Pin 5x30x215mm REF 620030 Metalogix Self-Drill Half-Pin 5x40x215mm REF 620040 Metalogix Self-Drill Half-Pin 5x60x215mm REF 620060 Metalogix Self-Drill Half-Pin 5x80x215mm REF 620080