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
Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
These labels are deterministic app interpretations, not FDA categories.
The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
Code information
Item Number: 15-0028/08; UDI-DI: 04026575175222; Lot Number: 2535004;
