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U.S. Department of Health and Human Services

Class 2 Device Recall AIM/ART (ACE Retrograde Tibial Nail) System

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  Class 2 Device Recall AIM/ART (ACE Retrograde Tibial Nail) System see related information
Date Initiated by Firm February 06, 2018
Date Posted March 14, 2018
Recall Status1 Terminated 3 on April 02, 2019
Recall Number Z-1196-2018
Recall Event ID 79409
510(K)Number K972183  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product 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.
Code Information All lots
Recalling Firm/
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
Manufacturer 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.
FDA Determined
Cause 2
Under Investigation by firm
Action Zimmer Biomet sent an Urgent Medical Device Recall letter dated February 06, 2018 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to: 1. Review this notification and notify affected personnel of the contents. 2. Quarantine all affected product. Your Zimmer Biomet sales representative will remove it from your facility. 3. Complete the Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. DISTRIBUTOR: 1. Review this notification and notify affected team members of the contents.2. Quarantine affected product in your inventory. 3.Return affected product from your distributorship and from affected hospitals within your territory. a. Complete Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. International returns, request an International Return Authorization (IRA) Number by emailing zimmerbiometintlirarequests@zimmerbiomet.com 4. Return the Additional Accounts form to CorporateQuality.PostMarket@zimmerbiomet.com.
Quantity in Commerce Not known
Distribution Worldwide and US of Indiana and country of the Republic of Korea.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HSB and Original Applicant = ACE MEDICAL CO.