XTANT Medical Holdings

Units from one lot were mislabeled with an incorrect part number, identifying the device as a shorter screw length than it physically is.

Certain implants in the Irix-A Lumbar Fusion System were distributed while labeled with an incorrect expiration date.

Spinal fixation system implant screws marked "DNI" are not intended to be implanted and may not have been manufactured in accordance with released manufacturing specifications, and if implanted the screws may not have adequate strength or performance.

Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.