RegWardenFDA facility compliance records
Company

SeaSpine Orthopedics Corporation

9 recall(s) on record — most severe on record: Class II.

Recalls by year

FDA actions on record by year2024: 5 recalls; 2025: 2 recalls; 2026: 2 recalls2017201820192020202120222023520242202522026
  • Recalls (9)

Registered facilities (2)

Recalls & enforcement

  • Class IIOngoing2026-08-19
    The proximal thread depth of the spinal device is out of design specification.
  • Class IIOngoing2026-05-28
    Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
  • Class IIOngoing2025-11-17
    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 u…
  • Class IIOngoing2025-08-06
    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 instrumentat…
  • Class IIOngoing2024-10-29
    Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
  • Class IIOngoing2024-06-04
    Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
  • Class IIOngoing2024-05-17
    Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
  • Class IIOngoing2024-02-28
    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 IIOngoing2024-02-15
    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.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. We restate the public record only — measured facts, never risk verdicts.

Cite this record

RegWarden. “SeaSpine Orthopedics Corporation — FDA compliance profile.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/company/oo-10049589-seaspine-orthopedics-corporation/

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