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U.S. Department of Health and Human Services

Class 2 Device Recall Vanguard Complete Knee System

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  Class 2 Device Recall Vanguard Complete Knee System see related information
Date Initiated by Firm September 29, 2017
Create Date February 21, 2018
Recall Status1 Terminated 3 on April 17, 2019
Recall Number Z-0673-2018
Recall Event ID 79161
510(K)Number K023546  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Vanguard Complete Knee System, Vanguard CR Tibial Bearing 12x71/75, Item Number: 183442

Product Usage:
For use in total knee arthroplasty
Code Information Lot Number: 388680, Exp. Date 5/19/2022
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		 Knee implant components (tibial bearings) are labeled with the incorrect size.
FDA Determined
Cause 2		 Labeling mix-ups
Action Zimmer Biomet sent an Urgent Medical Device Recall letter dated September 29, 2017 to their customers. The letter identified the affected product, problems and actions to be taken. Customers were instructed to remove the affected product from inventory and provide to their Zimmer sales representative or, if the consignee is a distributor, to ship the affected product back to Zimmer. Consignees were also asked to complete a recall response form and send this back to the firm. Returns are being physically destroyed. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.
Quantity in Commerce 24
Distribution Worldwide Distribution - US Nationwide in the states of CA, GA, KS, LA, MA, MI, MN, OH, TX, VA, WA, WI, and the countries of Netherlands
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 = JWH and Original Applicant = BIOMET, INC.
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