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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-1197-2018
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 - 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
810510300 NAIL TIB DYN 10 X 30.0
810510315 NAIL TIB DYN 10 X 31.5
810510330 NAIL TIB DYN 10 X 33.0
810510345 NAIL TIB DYN 10 X 34.5
810510360 NAIL TIB DYN 10 X 36.0
810510375 NAIL TIB DYN 10 X 37.5
810510390 NAIL TIB DYN 10 X 39.0
810510405 NAIL TIB DYN 10 X 40.5
810510420 NAIL TIB DYN 10 X 42.0
810511255 NAIL TIB DYN 11 X 25.5
810511270 NAIL TIB DYN 11 X 27.0
810511285 NAIL TIB DYN 11 X 28.5
810511300 NAIL TIB DYN 11 X 30.0
810511315 NAIL TIB DYN 11 X 31.5
810511330 NAIL TIB DYN 11 X 33.0
810511345 NAIL TIB DYN 11 X 34.5
810511360 NAIL TIB DYN 11 X 36.0
810511375 NAIL TIB DYN 11 X 37.5
810511390 NAIL TIB DYN 11 X 39.0
810511405 NAIL TIB DYN 11 X 40.5
810511420 NAIL TIB DYN 11 X 42.0
810512270 NAIL TIB DYN 12 X 27.0
810512285 NAIL TIB DYN 12 X 28.5
810512300 NAIL TIB DYN 12 X 30.0
810512315 NAIL TIB DYN 12 X 31.5
810512330 NAIL TIB DYN 12 X 33.0
810512345 NAIL TIB DYN 12 X 34.5
810512360 NAIL TIB DYN 12 X 36.0
810512375 NAIL TIB DYN 12 X 37.5
810512390 NAIL TIB DYN 12 X 39.0
810512405 NAIL TIB DYN 12 X 40.5
810512420 NAIL TIB DYN 12 X 42.0
810513255 NAIL TIB DYN 13 X 25.5
810513285 NAIL TIB DYN 13MM X 28.5CM
810513300 NAIL TIB DYN 13MMX30.0 CM
810513315 NAIL TIB DYN 13MM X 31.5 CM
810513330 NAIL TIB DYN 13 X 33.0
810513345 NAIL TIB DYN 13MM X 34.5 CM
810513360 NAIL TIB DYN 13 X 36.0 MM
810513375 NAIL TIB DYN 13MM X 37.5 CM
810513390 NAIL TIB DYN 13MMX39.0CM
810513405 NAIL TIB DYN 13MM X 40.5 CM
810513420 NAIL TIB DYN 13MM X 42 CM


Product Usage:
A metal rod which, when inserted into the intramedullary canal of the tibia, acts to immobilize by holding the ends of a fractured bone in position to promote healing. This device is non-sterile and must be sterilized prior to use. It is a single-use device.
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 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.
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