Class 2 Device Recall Vanguard Complete Knee System

• Date Initiated by Firm: September 29, 2017
• Create Date: February 21, 2018
• Recall Status: Terminated 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: 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