Recall Z-1350-2020— ulrich medical USA Inc
Class II · Terminated
Class II FDA medical device recall by ulrich medical USA Inc, initiated 2019-12-31, terminated 2025-11-17. It names one FDA 510(k) clearance: K150650. Product: Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw. 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..
- Recalling firm
- ulrich medical USA Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-12-31
- Terminated
- 2025-11-17
- Firm location
- Chesterfield, MO, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.