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.
Recall
- Recall Number
- Z-1605-2024
- Event Number
- 94164
- Firm
- SEASPINE ORTHOPEDICS CORPORATION
- FEI Number
- 3012120772
- Product Code
- NKB
- Status
- Open, Classified
- Root Cause
- Nonconforming Material/Component
- Initiated
- February 15, 2024
- Posted
- April 22, 2024
- Address
- 5770 Armada Dr, Carlsbad, CA, 92008-4608
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.
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.
On 2/14/24 the firm phoned distributors and informed them of the recall issue and next steps. On 2/16/24 the firm sent a recall communication via email. Customers were asked to arrange for the return of these sets along with any additional Mariner RDX inventory using a firm provided return label. Customers with questions or concerns can contact the Associate Product Manager, at [email protected]
US Nationwide distribution in the states of MI, GA, VA, IN, FL.
1579 Screw Heads