Spinal FrontiersPowered by NSpineSome Mariner deformity polyaxial heads were made with a proximal thread depth outside the design specification; 270 units in 18 US states are affected. Hospitals are told to stop using the lots, quarantine and return them via Orthofix.
- Type
- Recall
- Company
- SeaSpine (Orthofix)
- Device
- Mariner Deformity Extended Polyaxial Head, Attached Gimbal, 12 mm (REF MD1-300010-12)
- Date
- 19 August 2026
- Jurisdiction
- US
- Classification
- FDA Class II recall (Z-3226-2026; 510(k) K211606)
- Source
- FDA Medical Device Recalls database
Read the official notice →Source checked
What to do
Act on the regulator's or manufacturer's own notice; this page is a summary, not an official safety channel. If a device has failed or harmed a patient, see Report a Device Problem for who to tell in your country.