Mariner RDX Polyaxial Head, REF: MX1-000020; Mariner RDX Extended Polyaxial Head, REF: MX1-000030; Mariner RDX Deformity
FDA device recall Z-1605-2024 · posted 2024-04-22 · Open, Classified
Recall details
- Recalling firm
- SEASPINE ORTHOPEDICS CORPORATION
- 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.
- Action taken
- 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
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- NKB
- Quantity affected
- 1579 Screw Heads
- Distribution
- US Nationwide distribution in the states of MI, GA, VA, IN, FL.
- Date initiated
- 2024-02-15
- Date posted
- 2024-04-22
- Location
- Carlsbad, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Mariner RDX System (K222110) | SeaSpine Orthopedics Corporation | 2022-09-07 |