ulrich medical USA Inc Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
Brand
ulrich medical USA Inc
Lot Codes / Batch Numbers
Lot Numbers: U010577, U016620, U019084
Products Sold
Lot Numbers: U010577, U016620, U019084
ulrich medical USA Inc is recalling Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to due to 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 d. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, AR, CA, FL, GA, TX
Page updated: Jan 10, 2026