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
AIM Tibial Nails intramedullary fixation rod - STERILE; Item numbers: 800508255 NAIL TIB DYN 08X25.5 - STERILE 800508270 NAIL TIB DYN 08X27.0 - STERILE 800508285 NAIL TIB DYN 08X28.5 - STERILE 800508300 NAIL TIB DYN 08X30.0 - STERILE 800508315 NAIL TIB DYN 08X31.5 - STERILE 800508330 NAIL TIB DYN 08X33.0 - STERILE 800508345 NAIL TIB DYN 08X34.5 - STERILE 800508360 NAIL TIB DYN 08X36.0 - STERILE 800508375 NAIL TIB DYN 08X37.5 - STERILE 800508390 NAIL TIB DYN 08X39.0 - STERILE 800508405 NAIL TIB DYN 08X40.5 - STERILE 800508420 NAIL TIB DYN 08X42.0 - STERILE 800509255 NAIL TIB DYN 09X25.5 - STERILE 800509270 NAIL TIB DYN 09X27.0 - STERILE 800509285 NAIL TIB DYN 09X28.5 - STERILE 800509300 NAIL TIB DYN 09X30.0 - STERILE 800509315 NAIL TIB DYN 09X31.5 - STERILE 800509330 NAIL TIB DYN 09X33.0 - STERILE 800509345 NAIL TIB DYN 09X34.5 - STERILE 800509360 NAIL TIB DYN 09X36.0 - STERILE 800509375 NAIL TIB DYN 09X37.5 - STERILE 800509390 NAIL TIB DYN 09X39.0 - STERILE 800509405 NAIL TIB DYN 09X40.5 - STERILE 800509420 NAIL TIB DYN 09X42.0 - STERILE 800510255 NAIL TIB DYN 10X25.5 - STERILE 800510270 NAIL TIB DYN 10X27.0 - STERILE 800510285 NAIL TIB DYN 10X28.5 - STERILE 800510300 NAIL TIB DYN 10X30.0 - STERILE 800510315 NAIL TIB DYN 10X31.5 - STERILE 800510330 NAIL TIB DYN 10X33.0 - STERILE 800510345 NAIL TIB DYN 10X34.5 - STERILE 800510360 NAIL TIB DYN 10X36.0 - STERILE 800510375 NAIL TIB DYN 10X37.5 - STERILE 800510390 NAIL TIB DYN 10X39.0 - STERILE 800510405 NAIL TIB DYN 10X40.5 - STERILE 800510420 NAIL TIB DYN 10X42.0 - STERILE 800511270 NAIL TIB DYN 11X27.0 - STERILE 800511285 NAIL TIB DYN 11X28.5 - STERILE 800511300 NAIL TIB DYN 11X30.0 - STERILE 800511330 NAIL TIB DYN 11X33.0 - STERILE 800511345 NAIL TIB DYN 11X34.5 - STERILE 800511360 NAIL TIB DYN 11X36.0 - STERILE 800511375 NAIL TIB DYN 11X37.5 - STERILE 800511390 NAIL TIB DYN 11X39.0 - STERILE 800511405 NAIL TIB DYN 11X40.5 - STERILE 800511420 NAIL TIB DYN 11X42.0 - STERILE 800512270 NAIL TIB DYN 12X27.0 - STERILE 800512285 NAIL TIB DYN 12X28.5 - STERILE 800512300 NAIL TIB DYN 12X30.0 - STERILE 800512315 NAIL TIB DYN 12X31.5 - STERILE 800512330 NAIL TIB DYN 12X33.0 - STERILE 800512345 NAIL TIB DYN 12X34.5 - STERILE 800512360 NAIL TIB DYN 12X36.0 - STERILE 800512375 NAIL TIB DYN 12X37.5 - STERILE 800512390 NAIL TIB DYN 12X39.0 - STERILE 800512405 NAIL TIB DYN 12X40.5 - STERILE 800512420 NAIL TIB DYN 12X42.0 - STERILE 800513285 NAIL TIB DYN 13X28.5 - STERILE 800513300 NAIL TIB DYN 13X30.0 - STERILE 800513315 NAIL TIB DYN 13X31.5 - STERILE 800513330 NAIL TIB DYN 13X33.0 - STERILE 800513345 NAIL TIB DYN 13X34.5 - STERILE 800513360 NAIL TIB DYN 13X36.0 - STERILE 800513375 NAIL TIB DYN 13X37.5 - STERILE 800513390 NAIL TIB DYN 13X39.0 - STERILE 800513405 NAIL TIB DYN 13X40.5 - STERILE 800513420 NAIL TIB DYN 13X42.0 - STERILE Product Usage: A rod, when inserted into the intramedullary canal of the tibia, acts as an immobilization device to hold ends of a fractured bone in position.
The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.
Code information
All lots
Distribution pattern
Worldwide and US of Indiana and country of the Republic of Korea.
device · product 2 of 2
AIM Tibial Nails intramedullary fixation rod - NON-STERILE; Item numbers: 810508255 NAIL TIB DYN 08 X 25.5 810508270 NAIL TIB DYN 08 X 27.0 810508285 NAIL TIB DYN 08 X 28.5 810508300 NAIL TIB DYN 08 X 30.0 810508315 NAIL TIB DYN 08 X 31.5 810508330 NAIL TIB DYN 08 X 33.0 810508345 NAIL TIB DYN 08 X 34.5 810508360 NAIL TIB DYN 08 X 36.0 810508375 NAIL TIB DYN 08 X 37.5 810508390 NAIL TIB DYN 08 X 39.0 810508405 NAIL TIB DYN 08 X 40.5 810508420 NAIL TIB DYN 08 X 42.0 810509255 NAIL TIB DYN 09 X 25.5 810509270 NAIL TIB DYN 09 X 27.0 810509285 NAIL TIB DYN 09 X 28.5 810509300 NAIL TIB DYN 09 X 30.0 810509315 NAIL TIB DYN 09 X 31.5 810509330 NAIL TIB DYN 09 X 33.0 810509345 NAIL TIB DYN 09 X 34.5 810509360 NAIL TIB DYN 09 X 36.0 810509375 NAIL TIB DYN 09 X 37.5 810509390 NAIL TIB DYN 09 X 39.0 810509405 NAIL TIB DYN 09 X 40.5 810509420 NAIL TIB DYN 09 X 42.0 810510255 NAIL TIB DYN 10 X 25.5 810510270 NAIL TIB DYN 10 X 27.0 810510285 NAIL TIB DYN 10 X 28.5 810510300 NAIL TIB DYN 10 X 30.0 810510315 NAIL TIB DYN 10 X 31.5 810510330 NAIL TIB DYN 10 X 33.0 810510345 NAIL TIB DYN 10 X 34.5 810510360 NAIL TIB DYN 10 X 36.0 810510375 NAIL TIB DYN 10 X 37.5 810510390 NAIL TIB DYN 10 X 39.0 810510405 NAIL TIB DYN 10 X 40.5 810510420 NAIL TIB DYN 10 X 42.0 810511255 NAIL TIB DYN 11 X 25.5 810511270 NAIL TIB DYN 11 X 27.0 810511285 NAIL TIB DYN 11 X 28.5 810511300 NAIL TIB DYN 11 X 30.0 810511315 NAIL TIB DYN 11 X 31.5 810511330 NAIL TIB DYN 11 X 33.0 810511345 NAIL TIB DYN 11 X 34.5 810511360 NAIL TIB DYN 11 X 36.0 810511375 NAIL TIB DYN 11 X 37.5 810511390 NAIL TIB DYN 11 X 39.0 810511405 NAIL TIB DYN 11 X 40.5 810511420 NAIL TIB DYN 11 X 42.0 810512270 NAIL TIB DYN 12 X 27.0 810512285 NAIL TIB DYN 12 X 28.5 810512300 NAIL TIB DYN 12 X 30.0 810512315 NAIL TIB DYN 12 X 31.5 810512330 NAIL TIB DYN 12 X 33.0 810512345 NAIL TIB DYN 12 X 34.5 810512360 NAIL TIB DYN 12 X 36.0 810512375 NAIL TIB DYN 12 X 37.5 810512390 NAIL TIB DYN 12 X 39.0 810512405 NAIL TIB DYN 12 X 40.5 810512420 NAIL TIB DYN 12 X 42.0 810513255 NAIL TIB DYN 13 X 25.5 810513285 NAIL TIB DYN 13MM X 28.5CM 810513300 NAIL TIB DYN 13MMX30.0 CM 810513315 NAIL TIB DYN 13MM X 31.5 CM 810513330 NAIL TIB DYN 13 X 33.0 810513345 NAIL TIB DYN 13MM X 34.5 CM 810513360 NAIL TIB DYN 13 X 36.0 MM 810513375 NAIL TIB DYN 13MM X 37.5 CM 810513390 NAIL TIB DYN 13MMX39.0CM 810513405 NAIL TIB DYN 13MM X 40.5 CM 810513420 NAIL TIB DYN 13MM X 42 CM Product Usage: A metal rod which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding the ends of a fractured bone in position to promote healing. This device is non-sterile and must be sterilized prior to use. It is a single-use device.
The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.
These labels are deterministic app interpretations, not FDA categories.
Official device-enrichment evidence · Unknown
An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.
The AIM Tibial Nails failed a clinical analysis where the surgical revision rate exceeded the acceptance criteria in the Device Performance Review protocol for the implant system.
Code information
All lots
Distribution pattern
Worldwide and US of Indiana and country of the Republic of Korea.
