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

• Date Initiated by Firm: February 06, 2018
• Date Posted: March 14, 2018
• Recall Status: Terminated 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/ Manufacturer: Zimmer Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: 411 Technical Services; 574-371-3071
• 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: 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.