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 2
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
These labels are deterministic app interpretations, not FDA categories.
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
Code information
UDI-DI: 04026575257379 Lot Number: 2123225
Distribution pattern
US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.
device · product 2 of 2
LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/21
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
These labels are deterministic app interpretations, not FDA categories.
Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
Code information
UDI-DI: 04026575257393 Lot Number: 2123233
Distribution pattern
US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.
