FDA recall Z-1605-2024

SEASPINE ORTHOPEDICS CORPORATION · Class II · device

Product

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.

Distribution

US Nationwide distribution in the states of MI, GA, VA, IN, FL.

Key facts

Status
Ongoing
Initiation date
2024-02-15
Report date
2024-05-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Carlsbad, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1605-2024