# FDA recall Z-1823-2020

> **U&I CORP.** · Class II · device recall initiated 2019-01-30.

## 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 for recall

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.

## Distribution

US Nationwide distribution in the state of CA.

## Key facts

- **Recall number:** Z-1823-2020
- **Recalling firm:** U&I CORP.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-01-30
- **Report date:** 2020-05-06
- **Termination date:** 2020-11-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Uijeongbu-Si Gyeonggi-Do, N/A, Korea (the Republic of)

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1823-2020

## Citation

> AI Analytics. FDA recall Z-1823-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1823-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*