openFDA Device Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall
event_date_initiated coverage
June 01, 1997–June 30, 2026
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
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Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
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.
