Z-1605-2024Class II

Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner...

Name: Z-1605-2024 Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner...
Creator: Seaspine Orthopedics Corporation
Published: 2024-02-15
License: https://open.fda.gov/license/

SeaSpine Orthopedics Corporation / initiated 2024-02-15 / Open, Classified / root cause: manufacturing process

FDA source

SEASPINE ORTHOPEDICS CORPORATION began a recall of Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1-000040; Mariner RDX... on 2024-02-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1605-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-15
Posted: 2024-04-22
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.
Product code: NKB Thoracolumbosacral Pedicle Screw System
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.
Root cause tag: manufacturing process
FDA 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 [email protected]
Quantity in commerce: 1579 Screw Heads
Distribution: US Nationwide distribution in the states of MI, GA, VA, IN, FL.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1605-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1605-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-05-01	2024-04-22

Product code NKB

K222110Class IIMariner RDX SystemSeaSpine Orthopedics Corporation / cleared 2022-09-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)