ulrich medical USA Inc recalls Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw

Recall date

December 31, 2019

Source

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

Recall number

Z-1350-2020

FDA classification

Class II

Brand / firm

ulrich medical USA Inc

Sold / distributed

AZ, TX, GA, FL, AR, CA

Why it was recalled

Due to a production error, the weld seam of the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation.

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

What was recalled

Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw