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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 October 31, 2018
Create Date December 20, 2018
Recall Status1 Terminated 3 on April 01, 2020
Recall Number Z-0644-2019
Recall Event ID 81608
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 Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to reduce pain and increase hip mobility through long term cementless fixation of total or hemi hip arthroplasty in the femur of patients with an adequate bone stock to support the component. A system consisting of a stem, a ball head and a cup is used for the treatment of degenerative diseases or trauma of the hip. All Avenir Muller Stems are intended to provide connection to articulation with specified ball heads through the 12/14 taper. The stems may be used for total hip and hemi-hip arthroplasty. During total hip arthroplasty, the stems may be combined with constrained or semi-constrained acetabular systems.
Code Information Lot Number:2955599 UDI Number:(01) 00889024479456(17)230831(10)2955599
Recalling Firm/
Manufacturer
Zimmer GmbH
Sulzerallee 8
Winterthur Switzerland
Manufacturer Reason
for Recall
Mislabeled Labeled Avenir M¿ller Stem size 1, the stem inside the packaging is an Avenir M¿ller Stem size 2 .
FDA Determined
Cause 2
Process control
Action Zimmer Biomet issued Notices to the OUS consignees on October 31, 2018. Letter identifies action to be taken: Review this notice and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1  Certificate of Acknowledgement
Quantity in Commerce 13 units
Distribution International distribution in the countries of Germany and Switzerland.
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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