# FDA recall Z-1620-2024

> **SEASPINE ORTHOPEDICS CORPORATION** · Class II · device recall initiated 2024-02-28.

## Product

Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.

## Reason for recall

Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.

## Distribution

US: CA, FL, CO, TX

## Key facts

- **Recall number:** Z-1620-2024
- **Recalling firm:** SEASPINE ORTHOPEDICS CORPORATION
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-28
- **Report date:** 2024-05-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Carlsbad, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1620-2024

## Citation

> AI Analytics. FDA recall Z-1620-2024. Retrieved 2026-07-16 from https://api.ai-analytics.org/recall/Z-1620-2024. Source: US FDA. Licensed CC0.

---

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