Recall Z-1605-2024 ยท NKB Thoracolumbosacral Pedicle Screw System
SEASPINE ORTHOPEDICS CORPORATION
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: AMRDXT
| Date | Apr 22, 2024 (initiated Feb 15, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | 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 olivia.disanto@seaspine.com |
| Quantity | 1579 Screw Heads |
| Distribution | US Nationwide distribution in the states of MI, GA, VA, IN, FL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222110 | Mariner RDX System SeaSpine Orthopedics Corporation, Sep 7, 2022 |