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XTANT Medical Holdings, Inc recalls Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Recalled February 7, 2024 · FDA recall Z-0846-2024 · XTANT Medical Holdings
Hazard
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. · FDA Class II
Units
6
Sold at
US distribution in MI.
Description
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.
Product
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Manufacturer(s)
XTANT Medical Holdings, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →