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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 October 03, 2017
Create Date March 14, 2018
Recall Status1 Open3, Classified
Recall Number Z-1011-2018
Recall Event ID 79250
510(K)Number K113550  
Product Classification Prosthesis, knee, patello/femorotibial, semi-constrained, uncemented, porous, coated, polymer/metal/polymer - Product Code MBH
Product Vanguard CR Porous Femoral 62.5mm (Left Femur)

For use in total knee arthroplasty
Code Information Item #183066/Lot 132900; UDI-(01) 0088030427068 (17) 270816 (10) 132900
Recalling Firm/
Manufacturer
Zimmer Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
Manufacturer Reason
for Recall
The affected products are labeled as a 62.5mm LEFT Femur; however, the contents are a Vanguard 70mm RIGHT Femur.
FDA Determined
Cause 2
Error in labeling
Action The firm, Zimmer Biomet, sent an "URGENT MEDICAL DEVICE RECALL REMOVAL" letter dated October 3, 2017 to distributors and customers. The letter described the product, problem and actions to be taken. The customers were instructed to: 1. Review notification and ensure affected team member are aware of the contents 2. Immediately locate and quarantine affected product in your inventory. 3. Complete the Certification of Acknowledgement portion of Attachment 1  Inventory Return Certification Form via digital copy to: corporatequallity.postmarket@zimmerbiomet.com within three (3) days. 4. Immediately return all affected product from your distributorship and affected hospitals within your territory along with a completed Attachment 1  Inventory Return Certification Form to Zimmer Biomet via SMS, via email to: rgarequest@zimmerbiomet.com-specify "RECALL" as RGA type. 5. Identify additional accounts Zimmer Biomet has not notified. 6. Retain a copy of your recall acknowledgement and product return forms for your records. Questions or concerns can be directed to the customer call center at 1-574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday.
Quantity in Commerce 8
Distribution US Distribution to states of: FL, WI, MD, MO, and MI.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = MBH and Original Applicant = BIOMET MANUFACTURING CORP.
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