Spineology, Inc. has recalled approximately 190 Graft Tube instruments, which are used to deliver material during spinal surgery. The recall was issued because the Graft Tube shaft can detach from its funnel head if not used exactly as directed by the surgical technique guide. If a detachment occurs during a procedure, it could lead to surgical delays or the presence of a detached fragment within the surgical site. Healthcare facilities and surgeons should identify any affected units in their inventory and contact the manufacturer for further instructions.
The shaft of the tube may separate from the head during surgery, which could leave a piece of the device inside the patient or require additional surgical steps to retrieve the detached part, increasing the risk of infection or prolonged surgery.
Manufacturer contact and instruction
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.