Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw...
FDA Recall #Z-1350-2020 — Class II — December 31, 2019
Product Description
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
Reason for Recall
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.
Recalling Firm
ulrich medical USA Inc — Chesterfield, MO
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
179 units
Distribution
AZ, TX, GA, FL, AR, CA
Code Information
Lot Numbers: U010577, U016620, U019084
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated