SEASPINE ORTHOPEDICS CORPORATION: Medical Device Recall in 2024 - (Recall #: Z-1620-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: February 28, 2024

Date Posted: May 1, 2024

Recall Number: Z-1620-2024

Event ID: 94306

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.

Status: Ongoing

Product Quantity: 444 Screw Heads

Code Information:

REF/UDI-DI/Lots: MX1-001010/10889981298647/ AW161319D, AW164195D, AW166994D, AW167309D, AW167422D, AW169350F, AW169351F. AMRDXMIS/10889981303297/ AMRDXMIS-001, AMRDXMIS-002, AMRDXMIS-003, AMRDXMIS-004, AMRDXMIS-005

Distribution Pattern:

US: CA, FL, CO, TX

Voluntary or Mandated:

Voluntary: Firm initiated