Class 2 Device Recall Biomet Orthopedics Vanguard PS Open Box Femoral

• Date Initiated by Firm: August 31, 2007
• Date Posted: December 05, 2007
• Recall Status: Terminated on June 04, 2008
• Recall Number: Z-0123-2008
• Recall Event ID: 44814
• 510(K)Number: K023546
• Product Classification: Knee Prosthesis Component - 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 IN 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: 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 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