Recall Z-1350-2020
ulrich medical USA Inc · initiated December 31, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
Codes / lots: Lot Numbers: U010577, U016620, U019084
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.
FDA-determined cause: Process control
Action taken
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, l.milos@ulrichmedicalusa.com, Monday through Friday 8:00am to 5:00pm CST.
Details
- Recall number
- Z-1350-2020
- Initiated
- December 31, 2019
- Terminated
- November 17, 2025
- Product code
- KWP – Appliance, Fixation, Spinal Interlaminal
- Quantity
- 179 units
- Distribution
- AZ, TX, GA, FL, AR, CA
- Recalling firm
- ulrich medical USA Inc, Chesterfield, MO