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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: REF/UDI-DI/Lots: MX1-000020/10889981289751/AW161073C, AW164798D, AW164799D, AW164800E, AW164801E; MX1-000030/10889981289768/AW164802F, AW164803G, AW157588F, AW161074F, AW163331F; MX1-000040/10889981289775/AW157589D, AW164806E; MX1-000050/10889981289782/AW164807G, AW164808G, AW164809H, AW157590G, AW172902H; MX1-000060/10889981289799/AW157591D, AW161076E, AW164811E; MX1-000070/10889981289805/AW163350G, AW164812G, AW157592G, AW161077G; AMRDX/10889981291266/AMRDX-001, AMRDX-002, AMRDX-003, AMRDX-004, AMRDX-005, AMRDX-008, AMRDX-009; AMRDXTD/10889981295332/AMRDXTD-003, AMRDXTD-004, AMRDXTD-005
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full 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.
Product Codes/Lot Numbers:
REF/UDI-DI/Lots: MX1-000020/10889981289751/AW161073C, AW164798D, AW164799D, AW164800E, AW164801E; MX1-000030/10889981289768/AW164802F, AW164803G, AW157588F, AW161074F, AW163331F; MX1-000040/10889981289775/AW157589D, AW164806E; MX1-000050/10889981289782/AW164807G, AW164808G, AW164809H, AW157590G, AW172902H; MX1-000060/10889981289799/AW157591D, AW161076E, AW164811E; MX1-000070/10889981289805/AW163350G, AW164812G, AW157592G, AW161077G; AMRDX/10889981291266/AMRDX-001, AMRDX-002, AMRDX-003, AMRDX-004, AMRDX-005, AMRDX-008, AMRDX-009; AMRDXTD/10889981295332/AMRDXTD-003, AMRDXTD-004, AMRDXTD-005
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1605-2024
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