The Recall Desk

Manufacturer

SEASPINE ORTHOPEDICS CORPORATION

10 recalls in our database name SEASPINE ORTHOPEDICS CORPORATION as the manufacturing or recalling firm.

What the numbers show

Total
10
Critical
0
Severe
0
Most recent
2026-07-29

Of the 10 recalls from SEASPINE ORTHOPEDICS CORPORATION we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–10 of 10

  • ModerateFDA (Devices)·Z-0937-2026·2025-12-24

    Spinal navigation guide recalled for naming an incompatible toolcard system

    SeaSpine Orthopedics is recalling 310 NorthStar OCT Navigation items because the surgical technique guide incorrectly identified Medtronic Infinity toolcards as compatible.

    Product
    Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0mm Drill, REF: PC2-400140; Navigation, 4.5mm Drill, PC2-4001
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-2554-2025·2025-09-17

    Spinal inserters recalled over difficulty disengaging implants and incorrect UDI marking

    Reef TA Inserters, part number TA2-001003, are recalled because they may contribute to difficulty disengaging the implant or improper implant positioning, and may carry incorrect UDI-DI marking. 74 units are affected.

    Product
    Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0751-2025·2025-01-01

    Daytona Small Stature Locking Caps recalled for manufacturing defects

    SeaSpine Orthopedics is recalling 92 Daytona Small Stature CoCr Locking Caps due to manufacturing defects that prevent proper component mating. The devices were distributed in seven U.S. states.

    Product
    Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Version: N/A Product Description: Locking Cap Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0752-2025·2025-01-01

    FDA Recalls Medical Spine Component Due to Manufacturing Defects

    SEASPINE Orthopedics is recalling 191 Daytona Small Stature Ti Locking Caps due to manufacturing defects that prevent proper component mating.

    Product
    Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/A Product Description: Locking Cap Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2357-2024·2024-07-24

    Surgical Awl Recalled Due to Insufficient Weld Integrity

    SeaSpine Orthopedics is recalling the Meridian Angled Awl Fixed surgical instrument due to insufficient weld around the cap component that may fail under impaction forces during surgery.

    Product
    Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-2234-2024·2024-07-10

    Fathom Pedicle Retractor Blades Recalled for Manufacturing Defect

    SeaSpine Orthopedics recalls Fathom Pedicle-Based Retractor C/C Blades due to manufacturing defects that could cause bone fracture or damage during surgery. 21 units were distributed nationwide.

    Product
    Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2235-2024·2024-07-10

    Surgical retractor blade manufacturing defect could cause bone fracture

    SeaSpine Orthopedics is recalling Fathom Pedicle-Based Retractor C/C Blades due to manufacturing defects that could cause bone fracture. The recall affects 31 units distributed across nine US states.

    Product
    Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Caudal Blade Component: Yes, a component of a retractor blade
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1620-2024·2024-05-01

    Pedicle Screw Heads Recalled Due to Cross-Threading Risk During Surgery

    SeaSpine's Mariner RDX MIS pedicle screw heads may have partial threading that causes cross-threading at the screw head interface during implant installation. Affected units distributed in CA, FL, CO, and TX.

    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.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1605-2024·2024-05-01

    Mariner RDX Pedicle Screw Heads Recalled for Intraoperative Cross-Threading Risk

    SeaSpine Orthopedics is recalling Mariner RDX pedicle screw heads because the thin lead-in thread poses a risk of cross-threading within the locking cap/screw head interface during surgery.

    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. R
    Category
    Medical Device
    Distribution
    Distributed nationwide