FDA recall Z-1197-2018

Product

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 81051030

Reason for recall

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.

Distribution

Worldwide and US of Indiana and country of the Republic of Korea.

Key facts

Status

Terminated

Initiation date

2018-02-06

Report date

2018-04-04

Termination date

2019-04-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1197-2018