# FDA recall Z-0546-2020

> **SPINEART SA** · Class III · device recall initiated 2019-02-05.

## Product

Intersomatic JULIET Ti OL cage. For use in orthopedic spinal procedures

## Reason for recall

Inner blister pack label is incorrect and does not match the correct external box label.

## Distribution

US: CA    OUS: Unknowns

## Key facts

- **Recall number:** Z-0546-2020
- **Recalling firm:** SPINEART SA
- **Classification:** Class III
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-02-05
- **Report date:** 2019-12-04
- **Termination date:** 2021-04-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Plan-Les-Ouates, Switzerland

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0546-2020

## Citation

> AI Analytics. FDA recall Z-0546-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-0546-2020. Source: US FDA. Licensed CC0.

---

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