Mariner RDX Head (SeaSpine) – Screw Threading Risk (2024)
Thin lead-in thread may pose a risk of intraoperative cross-threading during screw installation.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
SEASPINE ORTHOPEDICS CORPORATION
Lot Codes / Batch Numbers
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
Products Sold
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
SEASPINE ORTHOPEDICS CORPORATION is recalling Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; M due to 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 i. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026