SEASPINE ORTHOPEDICS CORPORATION
8 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for SEASPINE ORTHOPEDICS CORPORATION and translate it into plain English — free weekly digest, optional same-day alerts.
- 2025-09-17FDA-DeviceClass IIReef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
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.
- 2025-01-01FDA-DeviceClass IIBrand 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
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
- 2025-01-01FDA-DeviceClass IIBrand 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
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
- 2024-07-24FDA-DeviceClass IIBrand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
- 2024-07-10FDA-DeviceClass IIBrand 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
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
- 2024-07-10FDA-DeviceClass IIBrand 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
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
- 2024-05-01FDA-DeviceClass IIMariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
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.
- 2024-05-01FDA-DeviceClass IIMariner 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.
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.
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