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SEASPINE ORTHOPEDICS Recalls
10 recalls on record · May 1, 2024 to July 29, 2026 · Medical Devices
Recalls by year
24
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 29, 2026Medical DevicesFDA
SEASPINE ORTHOPEDICS CORPORATION recalls SeaSpine Polyaxial Head REF Number: 41-3010
Hazard: Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
December 24, 2025Medical DevicesFDA
SEASPINE ORTHOPEDICS CORPORATION recalls Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Naviga
Hazard: The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However, the NorthStar OCT Navigation Instruments are compatible for use with Medtronic s Solera toolcards only.
September 17, 2025Medical DevicesFDA
SEASPINE ORTHOPEDICS CORPORATION recalls Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
Hazard: Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.
January 1, 2025Medical DevicesFDA
SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001
Hazard: Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
January 1, 2025Medical DevicesFDA
SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79
Hazard: Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
July 24, 2024Medical DevicesFDA
SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Descrip
Hazard: Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
July 10, 2024Medical DevicesFDA
SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product D
Hazard: Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
July 10, 2024Medical DevicesFDA
SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product D
Hazard: Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
May 1, 2024Medical DevicesFDA
SEASPINE ORTHOPEDICS CORPORATION recalls Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS,
Hazard: 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.
May 1, 2024Medical DevicesFDA
SEASPINE ORTHOPEDICS CORPORATION recalls Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformi
Hazard: 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.