Mariner RDX Pedicle Screw Heads Recalled for Intraoperative Cross-Threading Risk
SeaSpine Orthopedics is recalling Mariner RDX pedicle screw heads because the thin lead-in thread poses a risk of cross-threading within the locking cap/screw head interface during surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of spinal implant components with a documented risk of intraoperative surgical complication, but no reported illnesses or injuries. Per the severity rubric, risk-of-harm products without reported harm score at most 3.
Plain-English summary
SeaSpine Orthopedics Corporation is recalling six models of Mariner RDX pedicle screw heads: Polyaxial Head (REF MX1-000020), Extended Polyaxial Head (REF MX1-000030), Deformity Head (REF MX1-000040), Extended Deformity Head (REF MX1-000050), Trauma Head (REF MX1-000060), and Extended Trauma Head (REF MX1-000070). These components are part of the Mariner RDX Alpha Instruments and Implants and Mariner RDX TD Alpha Implants pedicle screw systems, which are used in spinal fusion and stabilization surgery.
The recalled screw heads have a thin lead-in thread that poses a risk of intraoperative cross-threading within the locking cap/screw head interface during surgical implantation.
A total of 1,579 screw heads have been distributed in Michigan, Georgia, Virginia, Indiana, and Florida.
Surgeons who have received these products should contact SeaSpine Orthopedics Corporation with any questions or concerns. Patients who have received these implants should consult with their surgeon about whether their device may be affected by this recall.
The recalled product
- Product
- 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. R
- Manufacturer
- SEASPINE ORTHOPEDICS CORPORATION
- Hazard
- cross-threading
- thread-defect
- surgical-complication-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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