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Class 2 Device Recall Biomet Orthopedics Vanguard PS Open Box Femoral |
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Date Initiated by Firm |
August 31, 2007 |
Date Posted |
December 05, 2007 |
Recall Status1 |
Terminated 3 on June 04, 2008 |
Recall Number |
Z-0123-2008 |
Recall Event ID |
44814 |
510(K)Number |
K023546
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Product Classification |
Knee Prosthesis Component - Product Code JWH
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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 IN 46581-0587
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For Additional Information Contact |
Paula Richardson 800-348-9500
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Manufacturer Reason for Recall |
Mislabeled as to size; labeled as 67.5 mm, actually contains 62.5 mm size femoral component.
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FDA Determined Cause 2 |
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
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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.
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510(K) Database |
510(K)s with Product Code = JWH and Original Applicant = BIOMET, INC.
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