Seaspine Orthopedics recalls
9 official recalls and safety alerts involving Seaspine Orthopedics since 2024-05, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Seaspine Orthopedics or the relevant agency.
- 2026-09-30
USSEASPINE ORTHOPEDICS CORPORATION recalls SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12
The proximal thread depth of the spinal device is out of design specification.
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONUS Nationwide distribution in the states of Alabama, California, Colorado,…Official notice →- 2026-07-29
- US
SEASPINE ORTHOPEDICS CORPORATION recalls SeaSpine Polyaxial Head REF Number: 41-3010
Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONWorldwide - US Nationwide distribution including in the states of Alabama,…Official notice → - 2025-12-24
- US
SEASPINE ORTHOPEDICS CORPORATION recalls Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation…
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,…
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONUS: CT, TX, NV, CO, CA, WA, NJ, OR, IN, MI, FL, PA, IL, VA, AL, RI, MO, AZ,…Official notice → - 2025-09-17
- US
SEASPINE ORTHOPEDICS CORPORATION recalls Reef 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,…
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONWorldwide - US Nationwide distribution in the states of NV, TX, ID, MI, OH,…Official notice → - 2025-01-01
- US
SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Model/Catalog Number: 79-0002…
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONU.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.Official notice → - 2024-07-24
- US
SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description:…
Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONThe product was distributed to the following US states: Nevada, Colorado,…Official notice → - 2024-07-10
- US
SEASPINE ORTHOPEDICS CORPORATION recalls Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number: MR2102050 Product…
Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONUnited States Nationwide distribution in the states of Nevada, Texas,…Official notice → - 2024-05-01
- US
SEASPINE ORTHOPEDICS CORPORATION recalls Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which…
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.
- US
SEASPINE ORTHOPEDICS CORPORATION recalls Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head,…
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.
FDA · DeviceSEASPINE ORTHOPEDICS CORPORATIONUS Nationwide distribution in the states of MI, GA, VA, IN, FL.Official notice →