Class 3 Device Recall Biomet Optivac Total Hip Kit

• Date Initiated by Firm: April 09, 2009
• Date Posted: June 30, 2009
• Recall Status: Terminated on October 06, 2010
• Recall Number: Z-1480-2009
• Recall Event ID: 52009
• Product Classification: Mixer, cement, for clinical use - Product Code JDZ
• Product: Biomet Optivac Total Hip Kit, Maximum Capacity Cartridge, 1 kit, sterile, latex free, Biomet Orthopedics, Inc., Warsaw, IN; Product Number: 418000. Vacuum mixing and vacuum collection system and application system for bone cement.
• Code Information: Lot Number: 607452.
• FEI Number: 1825034
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582
• For Additional Information Contact: 800-348-9500 Ext. 3983
• Manufacturer Reason for Recall: The package may contain two short mixing rods instead of one long and one short rod.
• FDA Determined Cause: Packaging process control
• Action: Biomet Orthopedics issued an "Urgent Medical Device Recall Notice" dated April 9, 2009 instructing distributors to visit each hospital consignee, deliver a copy of the recall notification and replacement product and to pick up, and return the affected product. Further questions may be addressed to the Biomet Orthopedics at 1-800-348-9500.
• Quantity in Commerce: 250
• Distribution: Nationwide Distribution - Including AL, AR, FL, IL, LA, MN, NE, NC, NV, OH, OK, SC, SD, WA and WI.
• 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.