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Seaspine Orthopedics Corporation FDA Recalls
11 recalls on file across devices, 0 of them Class I and 11 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12Class IIAug 19, 2026The proximal thread depth of the spinal device is out of des |
| SeaSpine Polyaxial Head REF Number: 41-3010Class IIMay 28, 2026Due to manufacturing error, polyaxial head may popoff from |
| Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; NavigaClass IINov 17, 2025The NorthStar OCT Navigation Surgical Technique Guide (STG) |
| Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody SystemClass IIAug 6, 2025Inserter, used as part of a system with an intervertebral bo |
| Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001Class IIOct 29, 2024Due to manufacturing defects observed on Locking Caps that a |
| Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79Class IIOct 29, 2024Due to manufacturing defects observed on Locking Caps that a |
| Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product DescripClass IIJun 4, 2024Insufficient weld around the cap component of the instrument |
| Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product DClass IIMay 17, 2024Cranial Caudal Blades manufactured incorrectly could result |
| Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product DClass IIMay 17, 2024Cranial Caudal Blades manufactured incorrectly could result |
| Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, Class IIFeb 28, 2024Screw heads, of pedicle screw systems, have partial thread w |
| Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX DeformiClass IIFeb 15, 2024Screw heads, of pedicle screw systems, have thin lead-in thr |