Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
Recall
- Recall Number
- Z-1350-2020
- Event Number
- 84638
- Firm
- ulrich medical USA Inc
- FEI Number
- 3005532635
- Product Code
- KWP
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- December 31, 2019
- Terminated
- November 17, 2025
- Address
- 18221 Edison Ave, Chesterfield, MO, 63005-3703
Description
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
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.
Ulrich notified initially notified customers, via phone call, on 12/20/2019. On about 12/31/2019, customers were also sent an official "URGENT SAFETY INFORMATION: MEDICAL DEVICE CORRECTIONS & REMOVALS" letter. Customers were informed that the "Locking screw for crosslink, screw-to-screw" cannot reliably transmit the required torque of 3.5 Nm during installation. Instructions included cease use of the affected devices, return them to Ulrich, and complete and return the provided "Product Recall" form. Customers were also instructed to inform all users of the devices within each organization are informed. Questions or concerns can be directed to Mr. Louis Milos, Sr. Manager Business and Quality Systems, at 636-519-0268 ext. 105, [email protected], Monday through Friday 8:00am to 5:00pm CST.
AZ, TX, GA, FL, AR, CA
179 units