Home / Recalls / ulrich medical USA Inc / Z-1350-2020

Z-1350-2020 Class II Terminated

Recalled by ulrich medical USA Inc — Chesterfield, MO

Recall Details

Product Type: Devices
Report Date: March 4, 2020
Initiation Date: December 31, 2019
Termination Date: November 17, 2025
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 179 units

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.

Distribution Pattern

AZ, TX, GA, FL, AR, CA

Code Information

Lot Numbers: U010577, U016620, U019084