Recall Z-1620-2024 ยท NKB Thoracolumbosacral Pedicle Screw System
SEASPINE ORTHOPEDICS CORPORATION
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
| Date | Apr 23, 2024 (initiated Feb 28, 2024) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | On 2/26/24, the firm phoned customers and informed them of the recall and that they would receive an email outlining details of the field action and subsequent steps to be taken. On 2/28/24, recall emails were sent to customers asking customers to respond to the emails to coordinate product return and replacement. Customers with questions can contact the firm at olivia.disanto@seaspine.com. |
| Quantity | 444 Screw Heads |
| Distribution | US: CA, FL, CO, TX |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222110 | Mariner RDX System SeaSpine Orthopedics Corporation, Sep 7, 2022 |