Class II — ulrich medical USA Inc
| Recalling firm | ULRICH MEDICAL USA, INC. |
|---|---|
| Registered facility | ULRICH MEDICAL USA, INC. (the firm's only registered facility) |
| Classification | Class II |
| 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. |
| Product | Ulrich medical neon3 OCT spinal stabilization, REF CS 3917-12, Locking screw for crosslink, screw-to-screw |
| Quantity | 179 units |
| Distribution | AZ, TX, GA, FL, AR, CA |
| Initiated | 2019-12-31 |
| Classified | 2020-02-24 |
| Terminated | 2025-11-17 |
| Recall number | Z-1350-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — ulrich medical USA Inc (Z-1350-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/84638/
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