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U.S. Department of Health and Human Services

Class 2 Device Recall Avenir Mller Stem

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  Class 2 Device Recall Avenir Mller Stem see related information
Date Initiated by Firm June 30, 2016
Date Posted July 26, 2016
Recall Status1 Terminated 3 on March 27, 2017
Recall Number Z-2292-2016
Recall Event ID 74693
510(K)Number K123392  
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product Avenir M¿ller Stem 4 Standard
Avenir M¿ller Stem 6 Lateral

Hip joint metal/ceramic/polymer semi-constrained cemented or
nonporous uncemented prosthesis
Intended Use: " Advanced wear of the joint due to degenerative, post-traumatic or rheumatic diseases. " Failed previous hip surgery including joint reconstruction (osteotomy), arthrodesis, hemiarthroplasty or total hip replacement (THR). " Acute traumatic fracture of the femoral head or neck " Avascular necrosis of the femoral head. " Avenir Moller Stems are for cementless use only.
Code Information Item Name: Avenir M¿ller Stem 4 Standard Item Number: 01.06010.004 Lot Number: 4022860  Item Name: Avenir M¿ller Stem 6 Lateral Item Number: 01.06010.106 Lot Number: 4023094
Recalling Firm/
Manufacturer		 Zimmer Gmbh
Sulzer Allee 8
Winterthur Switzerland
For Additional Information Contact customer call center
800-348-2759
Manufacturer Reason
for Recall		 Product mix-up. The Avenir M¿ller Stem 6 lateral uncemented might be placed in the packaging of the Avenir M¿ller Stem 4 standard uncemented and vice versa. Potential for delay in surgery, and/or potential for use of incorrect implant which may in turn lead dismetry in patient and possibly the need for revision.
FDA Determined
Cause 2		 Labeling mix-ups
Action Zimmer Biomet sent an Urgent Medical Device Recall letter dated June 30, 2016 to all affected customers via courier. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to review the notification immediately and ensure affected personnel are aware of the contents and assist Zimmer Biomet sales representative with the quarantine of any affected device. Your Zimmer Biomet sales representative will remove any affected device. Customers were also instructed to complete the Certification of Acknowledgement form and return to corporatequality.postmarket@zimmerbiomet.com. Customers with further questions or concerns were instructed to contact the customer call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST. For questions regarding this recall call 800-348-2759.
Quantity in Commerce 2
Distribution Nationwide Distribution to OH and NM
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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