Mariner RDX MIS Polyaxial Head — Class II medical device recall Z-1620-2024
Ongoing recall by SEASPINE ORTHOPEDICS CORPORATION, reported 2024-05-01, distributed in CA, CO, FL, TX. Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoper
| Recall number | Z-1620-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SEASPINE ORTHOPEDICS CORPORATION, Carlsbad, CA, United States |
| Recall initiated | 2024-02-28 |
| Classified | 2024-04-23 |
| Reported by FDA | 2024-05-01 |
| Distributed | CA, CO, FL, TX |
| Quantity | 444 screw |
| UPC / GTIN / UDI-DI | 10889981298647, 10889981303297 |
| Lot numbers | AMRDXMIS-001, AMRDXMIS-002, AMRDXMIS-003, AMRDXMIS-004, AMRDXMIS-005, AMRDXMIS/10889981303297, AW161319D, AW164195D, AW166994D, AW167309D, AW167422D, AW169350F, AW169351F, MX1-001010/10889981298647 |
| Model numbers | MX1-001010 |
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.
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-1620-2024. 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.