Recall Z-3226-2026— SEASPINE ORTHOPEDICS CORPORATION

Name: FDA recall Z-3226-2026
Creator: U.S. Food and Drug Administration
Published: 2026-08-19

Class II · Ongoing

Class II FDA medical device recall by SEASPINE ORTHOPEDICS CORPORATION, initiated 2026-08-19. It names one FDA 510(k) clearance: K211606. Product: SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12. Reason: The proximal thread depth of the spinal device is out of design specification..

Recalling firm: SEASPINE ORTHOPEDICS CORPORATION
Classification: Class II
Status: Ongoing
Initiated: 2026-08-19
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K211606 — Mariner Deformity SystemSeaSpine Orthopedics Corporation·cleared 2021-06-23

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head, Attached Gimbal, 12mm REF: MD1-300010-12

Reason for recall

The proximal thread depth of the spinal device is out of design specification.

Data sourced from openFDA. This site is unofficial and independent of the FDA.