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U.S. Department of Health and Human Services

Class 2 Device Recall Vanguard 360 Revision Knee System

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 Class 2 Device Recall Vanguard 360 Revision Knee Systemsee related information
Date Initiated by FirmAugust 02, 2018
Create DateSeptember 25, 2018
Recall Status1 Terminated 3 on April 25, 2019
Recall NumberZ-3249-2018
Recall Event ID 80904
510(K)NumberK093293 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductVanguard 360 Revision Knee System 63x 10mm Universal Tibial Block Augment, Model Number 185221 Intended for use in Total Knee Arthroplasty
Code Information Lot 320390, UDI (01) 0088030448157 (17) 230129 (10) 320390
Recalling Firm/
Manufacturer
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact411 Technical Services
574-371-3071
Manufacturer Reason
for Recall
The implant only has one bolt in the sterile package but it should have had two.
FDA Determined
Cause 2
Under Investigation by firm
ActionThe firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL" notification letters dated 8/2/18 to customers on 8/2/18. The letters described the product, problem and actions to be taken. The letters instruct customers to perform the following actions: Risk Manager Responsibilities: 1. Review this notification 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 and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. 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. Distributors: 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1  Inventory Return Certification Form and send to CorporateQuality.PostMarket@zimmerbiomet.com within three (3) days. b. For each return, send a copy of Attachment 1 to CorporateQuality.PostMarket@zimmerbiomet.com. c. Include a hardcopy of Attachment 1 in each carton of your retur
Quantity in Commerce16
DistributionWorldwide Distribution: US (nationwide) to the following US states: AZ, KS, NM, NV, and UT; and to countries of: Australia and Netherlands.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JWH
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