medical Class II Updated 2020-03-04

ulrich medical USA Inc recalls Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-1

Recalled Product

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


Hazard / Issue

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.

Issued by

FDA

Affected States: AZ, TX, GA, FL, AR, CA
Lot/Code Info: Lot Numbers: U010577, U016620, U019084
View official government recall

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