Food, drugs, devices › SEASPINE ORTHOPEDICS CORPORATION
Device recall: Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS,
FDA enforcement event 94306 is a device recall by SEASPINE ORTHOPEDICS CORPORATION of Carlsbad, CA, initiated 28 Feb 2024 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 970 device enforcement events initiated in 2024 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. SEASPINE ORTHOPEDICS CORPORATION has 8 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
SEASPINE ORTHOPEDICS CORPORATION, Carlsbad, CA.
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."
Distribution
"US: CA, FL, CO, TX"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1620-2024 | Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems. | 444 Screw Heads | Class II | Ongoing | 1 May 2024 |
Context
Other enforcement events for SEASPINE ORTHOPEDICS CORPORATION
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 28 May 2026 | SeaSpine Polyaxial Head REF Number: 41-3010 | Device | Class II | 1 |
| 17 Nov 2025 | Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigat | Device | Class II | 1 |
| 6 Aug 2025 | Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System | Device | Class II | 1 |
| 29 Oct 2024 | Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0 | Device | Class II | 2 |
| 4 Jun 2024 | Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Descriptio | Device | Class II | 1 |
| 17 May 2024 | Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Desc | Device | Class II | 2 |
| 15 Feb 2024 | Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity | Device | Class II | 1 |
All 8 events for SEASPINE ORTHOPEDICS CORPORATION
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "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."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US: CA, FL, CO, TX"
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.