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.
Opening this dossier never hides products that did not match a prior timeline filter.
device · product 1 of 1
GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic
The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts).
These labels are deterministic app interpretations, not FDA categories.
The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts).
Code information
Lot Number 12LM03798
Distribution pattern
International only: Germany, France, United Arab Emirates, and United Kingdom.
