Recall Z-1620-2024— SEASPINE ORTHOPEDICS CORPORATION

Name: FDA recall Z-1620-2024
Creator: U.S. Food and Drug Administration
Published: 2024-02-28

Class II · Ongoing

Class II FDA medical device recall by SEASPINE ORTHOPEDICS CORPORATION, initiated 2024-02-28. It names one FDA 510(k) clearance: K222110. Product: Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.. Reason: Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface..

Recalling firm: SEASPINE ORTHOPEDICS CORPORATION
Classification: Class II
Status: Ongoing
Initiated: 2024-02-28
Firm location: Carlsbad, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K222110 — Mariner RDX SystemSeaSpine Orthopedics Corporation·cleared 2022-09-07

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

Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.

Reason for recall

Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.

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