Class 2 Device Recall Biomet brand Discovery Elbow

• Date Initiated by Firm: May 23, 2008
• Date Posted: October 03, 2008
• Recall Status: Terminated on September 22, 2009
• Recall Number: Z-0033-2009
• Recall Event ID: 49465
• 510(K)Number: K013042
• Product Classification: Implant. - Product Code JDC
• Product: Biomet brand Discovery Elbow, 3 mm x 115 mm right ulna with bearing/bond coat, TI 6AL 4V Alloy/ARCOM UHMWPE, For cemented use only, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 114817. The product intended use is for Orthopedic implant.
• Code Information: Lot 440370.
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582
• For Additional Information Contact: 574-267-6639
• Manufacturer Reason for Recall: The component in the package is not the correct size.
• FDA Determined Cause: Packaging process control
• Action: Consignees were notified by letter dated May 28, 2008 to locate and return the recalled lots. Contact Biomet Orthopedics at 1-800-348-9500, ext. 3983 for assistance.
• Quantity in Commerce: 5
• Distribution: USA--California, Illinois, Indiana, Massachusetts, Ohio Puerto Rico, and Canada, OUS: Germany and Great Britain.
• 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 = JDC and Original Applicant = BIOMET ORTHOPEDICS, INC.