SEASPINE ORTHOPEDICS CORPORATION recall records

10 reported ongoing

10 records in this archive. Latest source date May 28, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

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

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 Instrumen...

Class IIReported ongoing

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

Official source for Orthofix NorthStar OCT Navigation Surgical Technique Guide, and instruments: Navigation Driver, R...
FDA device enforcement

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, intraoperative revision, and may require the use of ...

Class IIReported ongoing

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.

Official source for Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System
FDA device enforcement

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 Ca...

Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.

Class IIReported ongoing

Distribution: U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.

Official source for Brand Name: Daytona Small Stature Product Name: CoCr LockingCap 4.5mm, Small Stature, T25, BT Mod...
FDA device enforcement

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 Com...

Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.

Class IIReported ongoing

Distribution: U.S. Nationwide distribution in the states of CA, CO, FL, GA, PA, TX, and VA.

Official source for Brand Name: Daytona Small Stature Product Name: Ti Locking Cap 4.5mm, Small Stature, T25 Model/Ca...
FDA device enforcement

Brand 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.

Class IIReported ongoing

Distribution: The product was distributed to the following US states: Nevada, Colorado, Texas, Washington, Indiana, Georgia, Michigan, Florida, Pennsylvania, Illinois, Tennessee, Virginia, Mi...

Official source for Brand Name: Meridian Angled Awl Fixed Product Name: Angled Awl Fixed Model/Catalog Number: RA2-00...
FDA device enforcement

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...

Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure

Class IIReported ongoing

Distribution: United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.

Official source for Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 35-55mm Model/Catalog Number:...
FDA device enforcement

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...

Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure

Class IIReported ongoing

Distribution: United States Nationwide distribution in the states of Nevada, Texas, Michigan, Rhode Island, California, Oregon, Oklahoma, New York, Minnesota.

Official source for Brand Name: Fathom Pedicle-Based Retractor Product Name: C/C Blade, 50-80mm Model/Catalog Number:...
FDA device enforcement

Mariner 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.

Class IIReported ongoing

Distribution: US: CA, FL, CO, TX

Official source for Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Im...
FDA device enforcement

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 He...

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.

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of MI, GA, VA, IN, FL.

Official source for Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030...

Reasons in these listed records

  • Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
  • 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 fo...
  • 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 instrument...
  • Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.

These examples come from this result page and are not a ranking of every recall reason.

Checking SEASPINE ORTHOPEDICS CORPORATION

Is there a recall on seaspine orthopedics corporation right now?

This archive contains 10 records, including 10 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

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Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

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