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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: All lots
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Zimmer Biomet, Inc.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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 Codes/Lot Numbers:
All lots
Distribution:
Distributed in: US
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1196-2018
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