XTANT Medical Holdings, Inc. is recalling 6 units of its Cortera Spinal Fixation System screws because they were manufactured with the wrong parts and are mislabeled. The screws are labeled as having an 8.5 mm diameter and 50 mm length, but they are actually smaller 5.5 mm diameter and 45 mm length screws. This error occurred because an incorrect screw shank component was used during manufacturing, which could prevent the screw from properly engaging or securing during a spinal procedure.
If a surgeon attempts to use these mislabeled screws, the device may fail to engage with the bone or surgical hardware due to the smaller size. This could lead to surgical delays or the need for additional medical intervention if the incorrect size is not identified before or during the procedure.
Manufacturer Notification and Device Return
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.
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Sources: FDA iRES · Raw API Response
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