Z-1350-2020Class II

Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw

Name: Z-1350-2020 Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
Creator: ulrich medical USA Inc
Published: 2019-12-31
License: https://open.fda.gov/license/

ulrich medical USA Inc / initiated 2019-12-31 / Terminated / root cause: manufacturing process

FDA source

ulrich medical USA Inc began a recall of Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw on 2019-12-31. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1350-2020
Classification: Class II
Status: Terminated
Initiated: 2019-12-31
Posted: 2020-03-02
Terminated: 2025-11-17
Recalling firm: ulrich medical USA Inc
Product: Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
Product code: KWP Appliance, Fixation, Spinal Interlaminal
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 179 units
Distribution: AZ, TX, GA, FL, AR, CA
Product codes and lots: Lot Numbers: U010577, U016620, U019084

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1350-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1350-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-04	2020-02-24

Product code KWP

K150650Class IIneon3Ulrich GmbH & Co. KG / cleared 2015-09-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)