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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Orthopedics Vanguard PS Open Box Femoral

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 Class 2 Recall
Biomet Orthopedics Vanguard PS Open Box Femoral
see related information
Date Posted December 05, 2007
Recall Status1 Terminated on June 04, 2008
Recall Number Z-0123-2008
Recall Event ID 44814
Premarket Notification
510(K) Number
K023546 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Biomet Orthopedics, Vanguard PS Open Box Femoral, 67.5 mm Left-Interlok, For Cemented Use Only, CO-CR-MO Alloy, REF 183130, Knee Prosthesis Component, Biomet Orthopedics, Inc., Warsaw, IN 46581
Code Information Lot Number: 395450.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46581-0587
For Additional Information Contact Paula Richardson
800-348-9500
Manufacturer Reason
for Recall
Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Biomet notified consignees via letter dated 8/31/07, titled Urgent Medical Device Recall Notice to immediately discontinue use of the product and to return units to Biomet.
Quantity in Commerce 16
Distribution Nationwide.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = BIOMET, INC.
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