The FDA has posted 5 enforcement recalls from Seaspine Orthopedics Corporation since 2025, none of them Class I (most serious). Most recent report: Jul 29, 2026.
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.…
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…
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
Firm name as filed with the FDA: “SEASPINE ORTHOPEDICS CORPORATION”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.