Zimmer Biomet, Inc.: Medical Device Recall in 2018 - (Recall #: Z-1196-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: February 6, 2018

Date Posted: April 4, 2018

Recall Number: Z-1196-2018

Event ID: 79409

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.

Status: Terminated

Product Quantity: Not known

Code Information:

All lots

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated