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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Biomet

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  Class 2 Device Recall Zimmer Biomet see related information
Date Initiated by Firm December 21, 2018
Create Date February 23, 2019
Recall Status1 Terminated 3 on May 13, 2020
Recall Number Z-0937-2019
Recall Event ID 82004
510(K)Number K040770  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Vanguard Knee System Series-A Standard Patella sizes 31mm
Item Number: 184764
Code Information Lot Number: 399960 UDI Number: (01)00880304431317(17)230302(10)399960  
Recalling Firm/
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact 411 Technical Services
Manufacturer Reason
for Recall
Vanguard Knee System Series-A Standard Patella a potential commingle that could result in the size of the implant not matching the size on the label.
FDA Determined
Cause 2
Under Investigation by firm
Action Zimmer Biomet conduct this recall to distributors and hospital risk managers that have unconsumed consigned inventory or inventory within their territory. Distributors notified via email on 12/21/18. Hospital risk managers, as well as distributors with product, will be notified via courier. Distributors issued letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals who have unconsumed inventory on hand. Distributors to return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers be provided with a letter identifying the issue and their responsibilities. These responsibilities include: - Assisting the Zimmer Biomet sales representative with the quarantine of the product - Returning Certificate of Acknowledgement to Zimmer Biomet. Questions or concerns after reviewing notice, call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday
Quantity in Commerce 45 units
Distribution MN, VA Foreign: Korea, New Zealand and Japan
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 MANUFACTURING, INC.