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U.S. Department of Health and Human Services

Class 2 Device Recall Vanguard Complete Knee System: Cruciate Retaining

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  Class 2 Device Recall Vanguard Complete Knee System: Cruciate Retaining see related information
Date Initiated by Firm August 09, 2016
Date Posted October 18, 2016
Recall Status1 Terminated 3 on May 17, 2017
Recall Number Z-0111-2017
Recall Event ID 75237
510(K)Number K023546  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Vanguard Distal Femoral Augment 75 X 5 RL/LM

Product Usage:
 Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.  Correction of varus, valgus, or posttraumatic deformity.  Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.  The device is a single use implant intended for implantation with bone cement.
Code Information Item Number 184108 Lot Number 183410 Exp. 8/27/2025
Recalling Firm/
Manufacturer		 Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Customer Service
800-348-9500 Ext. 1251
Manufacturer Reason
for Recall		 Contents of the package do not match the product labeling. Product is labeled: Vanguard Distal Femoral Augment 75 X 5 RL/LM Carton contains: Vanguard Distal Femoral Augment 75 X 5 LL/RM Risks: Adverse health outcomes that could occur as a result of this event are a delay less than 30 minutes and a different size augment being used to complete the procedure. As the augment will not assemble with femoral component due to its shape, it would be easily identified during surgery.
FDA Determined
Cause 2		 Labeling mix-ups
Action On 8/9/2016, URGENT MEDICAL DEVICE RECALL REMOVAL notifications were sent to the affected consignees 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. If after reviewing this notice you have further questions or concerns please call 1-800-348-9500 ext. 1251 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of operating hours will receive a call back the next business day. Alternatively, your questions may be sent by email to CPWARFieldAction@zimmerbiomet.com.
Quantity in Commerce 5
Distribution Worldwide Distribution - US Nationwide in the states of NJ, MI, FL and the countries of Sweden and Canada.
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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