Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS,
FDA device recall Z-1620-2024 · posted 2024-04-23 · Open, Classified
Recall details
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- NKB
- Quantity affected
- 444 Screw Heads
- Distribution
- US: CA, FL, CO, TX
- Date initiated
- 2024-02-28
- Date posted
- 2024-04-23
- Location
- Carlsbad, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Mariner RDX System (K222110) | SeaSpine Orthopedics Corporation | 2022-09-07 |