SeaSpine Orthopedics Corporation has recalled 1,579 Mariner RDX pedicle screw heads used in spinal surgeries. The affected screw heads have a thin lead-in thread that can cause the components to cross-thread during an operation. This defect affects several models, including the Polyaxial, Deformity, and Trauma heads. If you have undergone spinal surgery involving these components, contact your healthcare provider for more information.
The thin lead-in thread on the screw heads can cause the locking cap to misalign or cross-thread during installation. This can lead to surgical delays, improper fixation of the spinal hardware, or the need for additional procedures to replace the compromised components.
Professional medical follow-up and manufacturer consultation.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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