PREMIA SPINE LTD has recalled 30 units of the TOPS Inserter, which is used as part of the TOPS System Instrument Set for spinal implant surgeries. The recall was issued because pins may be missing from the tip of the inserter. If a pin is missing, the tool may not function as intended during surgical procedures, potentially impacting the success of the implant. Hospitals and surgical centers should contact the manufacturer or their distributor to arrange for a return or replacement.
Missing pins at the tip of the surgical inserter can cause the tool to malfunction during spinal implantation. This defect could lead to surgical complications or delays while the patient is under anesthesia if the surgeon cannot properly place the implant.
Part of the TOPS System Instrument Set used for implantation of the TOPS System.
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.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.