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 3
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software Version: N/A Product Description: rTSA Reamer, 42mm Component: Not a component
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Release of Material/Component prior to receiving test results
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Code information
Lot Code: Part Number: 321-59-42, UDI-DI: 10885862593009, Lot Number: 410398-013
Distribution pattern
U.S.: SC O.U.S.: N/A
device · product 2 of 3
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product Description: rTSA Reamer, 46mm Component: Not a component
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Release of Material/Component prior to receiving test results
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Code information
Lot Code: Part Number: 321-59-46, UDI: 10885862605535, Lot Number: 410398-014
Distribution pattern
U.S.: SC O.U.S.: N/A
device · product 3 of 3
Brand Name: Equinoxe Ergo Product Name: Ergo Augments Pilot Tip Converter Model/Catalog Number: 301-11-11 Software Version: N/A Product Description: Pilot Tip Converter Piece Component: Not a component
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Sourced
Release of Material/Component prior to receiving test results
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
Code information
Lot Code: Part Number: 301-11-11, UDI: 10885862592934, Lot Number: 410413-001
