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.
Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
These labels are deterministic app interpretations, not FDA categories.
Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
Code information
UDI-DI/Lot: 00190446309833/629Z1085
Distribution pattern
US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.
device · product 2 of 2
EMPOWER 3D Knee Tibial Insert, REF: 341-14-708. Orthopedic implant component.
Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
These labels are deterministic app interpretations, not FDA categories.
Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
Code information
UDI-DI/Lot: 00888912167055/132T1085
Distribution pattern
US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.
