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
Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
These labels are deterministic app interpretations, not FDA categories.
The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
Code information
Lot Code # 101337 Model # 17-5000
Distribution pattern
Nationwide Distribution including CA, FL, OK, NY, NC, and IL.
device · product 2 of 2
Thinflap System Case The cases hold surgical instrumentation in place during handling and storage.
The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
These labels are deterministic app interpretations, not FDA categories.
The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.
Code information
Lot Code # 101465 Model # 19-5000
Distribution pattern
Nationwide Distribution including CA, FL, OK, NY, NC, and IL.
