Recall Z-2762-2026— SEASPINE ORTHOPEDICS CORPORATION

Name: FDA recall Z-2762-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-28

Class II · Ongoing

Class II FDA medical device recall by SEASPINE ORTHOPEDICS CORPORATION, initiated 2026-05-28. It names one FDA 510(k) clearance: K173882. Product: SeaSpine Polyaxial Head REF Number: 41-3010. Reason: Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion..

Recalling firm: SEASPINE ORTHOPEDICS CORPORATION
Classification: Class II
Status: Ongoing
Initiated: 2026-05-28
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K173882 — SeaSpine Mariner Pedicle Screw SystemSeaSpine Orthopedics Corporation·cleared 2018-02-06

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 Polyaxial Head REF Number: 41-3010

Reason for recall

Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.

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