SeaSpine
2 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for SeaSpine and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-07-29FDA-DeviceClass IISeaSpine 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.
- 2025-12-24FDA-DeviceClass IICheck 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.
Get notified about new SeaSpine recalls
Free weekly digest. We email when a new federal recall affects SeaSpine or anything else in your household.
Get the Sunday Brief