PlainRecalls
FDA Devices Moderate Class II Ongoing

Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1-000040; Mariner RDX Extended Deformity Head, REF: MX1-000050; Mariner RDX Trauma Head, REF: MX1-000060; Mariner RDX Extended Trauma Head. REF: MX1-000070, part of Mariner RDX Alpha Instruments and Implants, REF: AMRDX and Mariner RDX TD Alpha Implants, REF: AMRDXTD, which are pedicle screw systems.

Reported: May 1, 2024 Initiated: February 15, 2024 #Z-1605-2024

Product Description

Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1-000040; Mariner RDX Extended Deformity Head, REF: MX1-000050; Mariner RDX Trauma Head, REF: MX1-000060; Mariner RDX Extended Trauma Head. REF: MX1-000070, part of Mariner RDX Alpha Instruments and Implants, REF: AMRDX and Mariner RDX TD Alpha Implants, REF: AMRDXTD, which are pedicle screw systems.

Reason for Recall

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

Details

Units Affected
1579 Screw Heads
Distribution
US Nationwide distribution in the states of MI, GA, VA, IN, FL.
Location
Carlsbad, CA

Frequently Asked Questions

What product was recalled? ▼
Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity Head, REF: MX1-000040; Mariner RDX Extended Deformity Head, REF: MX1-000050; Mariner RDX Trauma Head, REF: MX1-000060; Mariner RDX Extended Trauma Head. REF: MX1-000070, part of Mariner RDX Alpha Instruments and Implants, REF: AMRDX and Mariner RDX TD Alpha Implants, REF: AMRDXTD, which are pedicle screw systems.. Recalled by SEASPINE ORTHOPEDICS CORPORATION. Units affected: 1579 Screw Heads.
Why was this product recalled? ▼
Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 1, 2024. Severity: Moderate. Recall number: Z-1605-2024.

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