FDA Device recall Z-1823-2020
Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The d…
- FDA Device
- Class II
- terminated
- Published 2020-05-06
On 2020-05-06 the FDA classified a Class II recall of Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The d… by U And I, citing the vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists of screw pullout, lossening, instabilit….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1823-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-01-30 |
| Published | 2020-05-06 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | U And I |
| Distribution | US |
Product
Velofix SA cervical cage, REF: TSA161207, TSA161208, TSA161209, TSA161210, TSA161407, TSA161408, TSA161409, TSA161410 - Product Usage:The device is indicated for anterior cervical interbody fusion procedures in skeletally mature patients with cervical disk disease at one level from C2-C3 disc to the C7-T1 disc. Each product is composed of four components: PEEK cage, titanium plate, and two titanium markers.
Reason
The vertical dimensions of screw-hole position in some standalone cages might be out of range in engineering drawings. A possibility exists of screw pullout, lossening, instability, or less bone-screw engagement than intended by physicians.
Identifiers
| code_info | Lots: A18K220, A18L065, A18L013, A18L014, A18L015, A18L018, A18L019, A18L020, A18L021 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1823-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.