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U.S. Department of Health and Human Services

Class 2 Device Recall Avenir Muller Stem

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  Class 2 Device Recall Avenir Muller Stem see related information
Date Initiated by Firm February 28, 2018
Create Date April 26, 2018
Recall Status1 Terminated 3 on October 25, 2019
Recall Number Z-1525-2018
Recall Event ID 79677
510(K)Number K123392  
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496
Code Information Lot Number: 2905496
Recalling Firm/
Manufacturer		 Zimmer GmbH
Sulzerallee 8
Winterthur Switzerland
Manufacturer Reason
for Recall		 A potential commingle that could result in the product in the package not matching the product on the outer label.
FDA Determined
Cause 2		 Error in labeling
Action On March 7, 2018 Field Safety Corrective Action Notices were hand delivered by Zimmer Biomet team members or their representatives. Customers were instructed to complete the following: 1.Review this notification for awareness of the contents. 2.Assist your Zimmer Biomet sales representative to quarantine immediately all affected implants. 3.Your Zimmer Biomet sales representative will remove the affected implants from your facility. 4.Complete Attachment 1  Certificate of Acknowledgement. a. Return a digital copy to fieldaction.emea@zimmerbiomet.com. b. Retain a copy of the Certificate of Acknowledgement with your field action records in the event of a compliance audit of your documentation. 5.If after reviewing the notice you have further questions or concerns please contact your Zimmer Biomet representative.
Distribution There was no distribution to the US. The distribution occurred to the following countries: Belgium, Switzerland, Germany, France, Canary Islands, Italy, and Thailand.
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 = LZO and Original Applicant = ZIMMER GMBH
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