Spineart SA is recalling approximately 242 PERLA TL 25D Spinal Screw systems used in surgical procedures to stabilize and immobilize spinal segments. The recall was initiated because of reports that the setscrews—essential components for securing the spinal rod—may be difficult to insert, fail to tighten to the required torque, or may be positioned askew even when torque is reached. This defect was identified in screws manufactured in Switzerland and distributed specifically within California and Kentucky. Because this is a specialized medical device used in surgery, patients who have recently undergone spinal procedures using the PERLA TL system should contact their surgeon or healthcare provider for information regarding their specific implant.
If a setscrew is not properly tightened or is positioned incorrectly, the spinal stabilization system may fail to adequately support the spine. This could lead to device loosening, loss of spinal alignment, or the need for additional corrective surgery.
Healthcare provider or 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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