Seaspine Orthopedics recalls
Seaspine Orthopedics appears in 11 official U.S. recall notices indexed by RecallRadar, most recently on 2026-09-30.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 11 |
|---|---|
| Published | 2024-05-01 to 2026-09-30 |
| By agency | FDA Device (11) |
| By classification | Class II (11) |
| By status | ongoing (11) |
| Distribution named in notices | AL, AZ, CA, CO, CT, FL, GA, IL, IN, MI, MN, MO, MS, MT, NJ, NV, NY, OK, OR, PA, RI, SC, SD, TN, TX, US, UT, VA, WA |
Recalls
- SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
FDA Device · Class II · 2026-09-30 · Seaspine Orthopedics
Reason: The proximal thread depth of the spinal device is out of design specification. - SeaSpine Polyaxial Head REF Number: 41-3010
FDA Device · Class II · 2026-07-29 · Seaspine Orthopedics
Reason: Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion. - Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012
FDA Device · Class II · 2025-12-24 · Seaspine Orthopedics
Reason: 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,… - Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
FDA Device · Class II · 2025-09-17 · Seaspine Orthopedics
Reason: 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… - Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Catalog Number: 79-0001 Software Version: N/…
FDA Device · Class II · 2025-01-01 · Seaspine Orthopedics
Reason: Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. - Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002 Software Versio…
FDA Device · Class II · 2025-01-01 · Seaspine Orthopedics
Reason: Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate. - Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Com…
FDA Device · Class II · 2024-07-24 · Seaspine Orthopedics
Reason: Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces. - Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number: MR2102035 Product Description: Cranial Ca…
FDA Device · Class II · 2024-07-10 · Seaspine Orthopedics
Reason: Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure - Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product Description: Cranial Ca…
FDA Device · Class II · 2024-07-10 · Seaspine Orthopedics
Reason: Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure - Mariner RDX Polyaxial Head, REF: MX1-000020
FDA Device · Class II · 2024-05-01 · Seaspine Orthopedics
Reason: 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. - Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle s…
FDA Device · Class II · 2024-05-01 · Seaspine Orthopedics
Reason: 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.