FDA-Device2024-02-07Class II
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
XTANT Medical Holdings, Inc
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.
Sold states
US distribution in MI.
Affected count
6
Manufactured in
664 Cruiser Ln, Belgrade, MT, United States
Products
Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0846-2024Don't want to check this manually?
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