Recall Z-1350-2020 ยท KWP Appliance, Fixation, Spinal Interlaminal
ulrich medical USA Inc
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
| Date | Dec 31, 2019 |
| Status | Terminated |
| Reason | 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 | 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 |
| Quantity | 179 units |
| Distribution | AZ, TX, GA, FL, AR, CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K150650 | neon3 Ulrich GmbH & Co. KG, Sep 24, 2015 |