XTANT Medical Holdings, Inc. is recalling two units of the XTANT Medical Xpress Pedicle Screw System (Dual Lead 6.5 x 50 mm) because they were mislabeled with an incorrect part number. This error identifies the device as being a shorter length than it actually is. No injuries or incidents have been reported to date regarding this specific labeling error.
A surgeon relying on the incorrect label may attempt to use a screw that is physically longer than intended for the patient's anatomy, which could lead to surgical complications or injury.
Recall #: Z-1773-2026; Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.
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
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