Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
Reported: May 1, 2024 Initiated: February 28, 2024 #Z-1620-2024
Product Description
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.
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.
Details
- Recalling Firm
- SEASPINE ORTHOPEDICS CORPORATION
- Units Affected
- 444 Screw Heads
- Distribution
- US: CA, FL, CO, TX
- Location
- Carlsbad, CA
Frequently Asked Questions
What product was recalled? ▼
Mariner RDX MIS Polyaxial Head, REF: MX1-001010, part of Mariner RDX MIS Alpha Instruments and Implants, REF: AMRDXMIS, which are pedicle screw systems.. Recalled by SEASPINE ORTHOPEDICS CORPORATION. Units affected: 444 Screw Heads.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 1, 2024. Severity: Moderate. Recall number: Z-1620-2024.
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