FDA Medical Device Recalls (openFDA)
SEASPINE ORTHOPEDICS CORPORATION: 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.
- Recall number
- Z-1605-2024
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- 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.
- Status
- Open, Classified
- Initiated
- 2024-02-15
- Posted
- 2024-04-22
- Terminated
- not on file
- Reason
- 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.
- Root cause
- Nonconforming Material/Component
- Action
- On 2/14/24 the firm phoned distributors and informed them of the recall issue and next steps. On 2/16/24 the firm sent a recall communication via email. Customers were asked to arrange for the return of these sets along with any additional Mariner RDX inventory using a firm provided return label. Customers with questions or concerns can contact the Associate Product Manager, at olivia.disanto@seaspine.com
- Quantity
- 1579 Screw Heads
- Distribution
- US Nationwide distribution in the states of MI, GA, VA, IN, FL.
- Lot, serial or model codes
- REF/UDI-DI/Lots: MX1-000020/10889981289751/AW161073C, AW164798D, AW164799D, AW164800E, AW164801E; MX1-000030/10889981289768/AW164802F, AW164803G, AW157588F, AW161074F, AW163331F; MX1-000040/10889981289775/AW157589D, AW164806E; MX1-000050/10889981289782/AW164807G, AW164808G, AW164809H, AW157590G, AW172902H; MX1-000060/10889981289799/AW157591D, AW161076E, AW164811E; MX1-000070/10889981289805/AW163350G, AW164812G, AW157592G, AW161077G; AMRDX/10889981291266/AMRDX-001, AMRDX-002, AMRDX-003, AMRDX-004, AMRDX-005, AMRDX-008, AMRDX-009; AMRDXTD/10889981295332/AMRDXTD-003, AMRDXTD-004, AMRDXTD-005
- 510(k) numbers
- ["K222110"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 3012120772
- Firm city
- Carlsbad
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28