Carlsbad, CA, United States

SEASPINE ORTHOPEDICS CORPORATION recalls

9 recalls recorded since 2018, most recently on 19 August 2026. 9 are listed as ongoing. Status and classification are as published by the FDA.

Recalls9

Ongoing (FDA)9

Terminated or completed0

Class I (FDA)0

Recall started: 19 August 2026
Reason: The proximal thread depth of the spinal device is out of design specification.
Distribution: US Nationwide distribution in the states of Alabama, California, Colorado, Connecticut, Florida, Georgia, Massachusetts, Michigan, Minnesota, Missouri, North Carolina, Nevada, New York, Oklahoma, Oregon, Tennessee, Texas, and Virginia.
Initiated: Voluntary: Firm initiated
Recall number: Z-3226-2026

SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12

Recall started: 28 May 2026
Reason: Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
Distribution: Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Illinois, Indiana, Kansas, Maryland, Michigan, Missouri, Mississippi, Montana, Nevada, Ohio, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washi
Initiated: Voluntary: Firm initiated
Recall number: Z-2762-2026

Recall started: 17 November 2025
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, the NorthStar OCT Navigation Instruments are compatible for use with Medtronic s Solera toolcards only.
Distribution: US: CT, TX, NV, CO, CA, WA, NJ, OR, IN, MI, FL, PA, IL, VA, AL, RI, MO, AZ, MS, SC, UT, NY, OK, SD. OUS: Australia, Mexico, Chile
Initiated: Voluntary: Firm initiated
Recall number: Z-0937-2026

Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, REF: PC2-400012; Navigation Straight Bone Probe, REF: PC2-400013; Navigation, 3.5mm Drill, REF: PC2-400135; Navigation, 4.0

Recall started: 6 August 2025
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 revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.
Distribution: Worldwide - US Nationwide distribution in the states of NV, TX, ID, MI, OH, SD, TN, PA, CT, CO, FL, WA, NC, OK, MN and the country of Hong Kong.
Initiated: Voluntary: Firm initiated
Recall number: Z-2554-2025

Recall started: 29 October 2024
Reason: Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Distribution: U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-0751-2025, Z-0752-2025

Brand 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
Brand 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

Recall started: 4 June 2024
Reason: Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
Distribution: The product was distributed to the following US states: Nevada, Colorado, Texas, Washington, Indiana, Georgia, Michigan, Florida, Pennsylvania, Illinois, Tennessee, Virginia, Missouri, South Dakota, California, Montana, Minnesota, Arizona
Initiated: Voluntary: Firm initiated
Recall number: Z-2357-2024

Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-003015 Product Description: Surgical Awl Component: No

Recall started: 17 May 2024
Reason: Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
Distribution: United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2235-2024, Z-2234-2024

Brand 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
Brand 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

Recall started: 28 February 2024
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.
Distribution: US: CA, FL, CO, TX
Initiated: Voluntary: Firm initiated
Recall number: Z-1620-2024

Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.

Recall started: 15 February 2024
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.
Distribution: US Nationwide distribution in the states of MI, GA, VA, IN, FL.
Initiated: Voluntary: Firm initiated
Recall number: Z-1605-2024

Mariner 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

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.