# FDA recall Z-1605-2024

> **SEASPINE ORTHOPEDICS CORPORATION** · Class II · device recall initiated 2024-02-15.

## Product

Mariner RDX Polyaxial Head, REF: MX1-000020;  Mariner RDX Extended Polyaxial Head, REF: MX1-000030;  Mariner RDX Deformity Head, REF: MX1-000040;  Mariner RDX Extended Deformity Head, REF: MX1-000050;  Mariner RDX Trauma Head, REF: MX1-000060;  Mariner RDX Extended Trauma Head. REF: MX1-000070,  part of Mariner RDX Alpha Instruments and Implants, REF: AMRDX and  Mariner RDX TD Alpha Implants, REF: AMRDXTD, which are pedicle screw systems.

## Reason for recall

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

## Distribution

US Nationwide distribution in the states of MI, GA, VA, IN, FL.

## Key facts

- **Recall number:** Z-1605-2024
- **Recalling firm:** SEASPINE ORTHOPEDICS CORPORATION
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-15
- **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-1605-2024

## Citation

> AI Analytics. FDA recall Z-1605-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1605-2024. Source: US FDA. Licensed CC0.

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