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U.S. Department of Health and Human Services

Class 2 Device Recall Vanguard Knee System PS Open Box Femoral Left, 62.5 mm

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  Class 2 Device Recall Vanguard Knee System PS Open Box Femoral Left, 62.5 mm see related information
Date Initiated by Firm October 22, 2018
Create Date November 21, 2018
Recall Status1 Terminated 3 on December 11, 2019
Recall Number Z-0495-2019
Recall Event ID 81472
510(K)Number K023546  K113550  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Vanguard Knee System -PS Open Box Femoral Left, 62.5 mm
Item Number: 183126
Code Information Lot Number: J6255863 UDI: (01)00880304270794(17)280411(10)J6265594
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		 Label on the outer carton or the patient labels does not match label on the inner sterile packaging
FDA Determined
Cause 2		 Labeling mix-ups
Action Zimmer issued recall letter on 10/22/18 via email and FedEx. Acountts requested to immediately locate and quarantine affected product in your inventory. Return affected product from your distributorship and from affected hospitals. Complete Inventory Return Certification Form. uestions 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.
Quantity in Commerce 8 units
Distribution AR, MO, MN, NJ, NY, OH, MN , NJ, VA
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 CORP.
510(K)s with Product Code = JWH and Original Applicant = BIOMET, INC.
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