Class II
Medical Device Recall: Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
XTANT Medical Holdings, Inc · November 28, 2023
Reason for Recall
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.
Distribution
US distribution in MI.
States Affected
IN, MI
Quantity Affected
6
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0846-2024
Status: ongoing
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