Mariner RDX Polyaxial Head — Class II medical device recall Z-1605-2024
Ongoing recall by SEASPINE ORTHOPEDICS CORPORATION, reported 2024-05-01, distributed nationwide. Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threa
| Recall number | Z-1605-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SEASPINE ORTHOPEDICS CORPORATION, Carlsbad, CA, United States |
| Recall initiated | 2024-02-15 |
| Classified | 2024-04-22 |
| Reported by FDA | 2024-05-01 |
| Distributed | Nationwide (US) |
| Quantity | 1,579 screw |
| UPC / GTIN / UDI-DI | 10889981289751, 10889981289768, 10889981289775, 10889981289782, 10889981289799, 10889981289805, 10889981291266, 10889981295332 |
| Lot numbers | AMRDX-002, AMRDX-003, AMRDX-004, AMRDX-005, AMRDX-008, AMRDX-009, AMRDX/10889981291266/AMRDX-001, AMRDXTD-004, AMRDXTD-005, AW157588F, AW157590G, AW157592G, AW161074F, AW161076E, AW161077G, AW163331F, AW164798D, AW164799D, AW164800E, AW164801E, AW164803G, AW164806E, AW164808G, AW164809H, AW164811E, AW164812G, AW172902H |
| Model numbers | MX1-000020, MX1-000030, MX1-000040, MX1-000050, MX1-000060, MX1-000070 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1605-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.