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.
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
These labels are deterministic app interpretations, not FDA categories.
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Code information
Lot Number: 168117318B, 168125017C UDI: 00817701020011
Distribution pattern
Distribution US Nationwide, Japan, and the Netherlands
device · product 2 of 5
Nextra Hammertoe Correction System 4.5 Middle and 3.2 Proximal Saw Cut SKU: NX-4532K-SC Orthopedic surgical instrument
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
These labels are deterministic app interpretations, not FDA categories.
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Code information
Lot Number: 168117318C, 168125017D UDI: 00817701020004
Distribution pattern
Distribution US Nationwide, Japan, and the Netherlands
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
These labels are deterministic app interpretations, not FDA categories.
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Code information
Lot Number: 168125017A UDI: 00817701020042
Distribution pattern
Distribution US Nationwide, Japan, and the Netherlands
device · product 4 of 5
Nextra Hammertoe Correction System 3.5 Middle and 3.2 Proximal Saw Cut SKU: NX-3532K-SC Orthopedic surgical instrument
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
These labels are deterministic app interpretations, not FDA categories.
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Code information
Lot Number: 168125017B UDI: 00817701020059
Distribution pattern
Distribution US Nationwide, Japan, and the Netherlands
device · product 5 of 5
Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
These labels are deterministic app interpretations, not FDA categories.
Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery
Code information
Lot Number: 168A27917C UDI: 00817701020837
Distribution pattern
Distribution US Nationwide, Japan, and the Netherlands
