XTANT Medical Holdings, Inc. is recalling 330 Cortera Spinal Fixation System Screws because they were not manufactured according to required specifications. These specific screws are marked with the letters "DNI" (Do Not Implant) and were never intended for clinical use. If these screws are implanted during surgery, they may lack the necessary strength to support the spine and could fail or break. No incidents or injuries have been reported to date.
If these non-specification screws are implanted, they may break or perform poorly, potentially leading to spinal instability, pain, or the need for additional corrective surgeries to replace the failing hardware.
Screws are marked "DNI" (Do Not Implant).
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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