SeaSpine recalls
3 federal recalls on file. We read every CPSC, FDA, USDA and NHTSA notice for SeaSpine and put it in plain English.
Recent recalls
SeaSpine Mariner Deformity spinal implant recalled for thread defectSeaSpine Orthopedics is recalling certain Extended Polyaxial Head spinal implants (model MD1-300010-12) because the proximal thread depth does not meet design specifications. This defect could affect the secure attachment of the device during spinal surgery. No injuries have been reported.
ModerateFDASep 30, 2026
- SeaSpine Polyaxial Head recalled for potential intraoperative pop-off
SeaSpine Orthopedics has recalled certain Polyaxial Head spinal implants (REF 41-3010) due to a manufacturing error that may cause the polyaxial head to detach from the screw during surgery after insertion. This could require additional surgical intervention. The recall affects 796 units distributed worldwide, including nationwide US distribution and locations in Chile and Australia.
ModerateFDAJul 29, 2026
- Check NorthStar OCT Navigation instrument compatibility
The instruction guide for SeaSpine's NorthStar OCT Navigation surgical instruments incorrectly states that the tools work with both Medtronic Solera and Infinity system toolcards. In fact, they only work with Solera toolcards. Using these instruments with an Infinity system toolcard could result in device malfunction during surgery.
ModerateFDADec 24, 2025