FDA recall Z-1350-2020

Product

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

AZ, TX, GA, FL, AR, CA

Key facts

Status

Terminated

Initiation date

2019-12-31

Report date

2020-03-04

Termination date

2025-11-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Chesterfield, MO, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1350-2020