Class 2 Device Recall Zimmer Alumina Ceramic Femoral Head

• Date Initiated by Firm: June 11, 2008
• Date Posted: November 21, 2008
• Recall Status: Terminated on November 10, 2009
• Recall Number: Z-0300-2009
• Recall Event ID: 48712
• 510(K)Number: K030724
• Product Classification: hip metal/ceramic/polymer semi-constrained cemented or non-porous uncemented prosthesis - Product Code LZO
• Product: Zimmer Alumina Ceramic Femoral Head, 12/14 taper, 28 mm diameter, neck length 0 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-028-02 and 00-6428-028-02. The Alumina Ceramic Femoral Heads are modular components used in total hip arthroplasty and indicated for patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur; patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis; patients suffering from disability due to previous fusion; patients with previously failed endoprostheses and/or total hip components in the operative extremity; and patients with acute neck fractures.
• Code Information: All lots.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 574-267-6131
• Manufacturer Reason for Recall: When used with cobalt/chromium hip stems, the average test values for ceramic head bursting falls below the guidance document limits if the taper is made by casting instead of by forging.
• FDA Determined Cause: Device Design
• Action: The firm issued Product Compatibility Update # 13, dated 6/11/08, to consignees informing them which products are not compatible, and thus should not be used in combination.
• Quantity in Commerce: 49,474 of all products
• Distribution: Worldwide Distribution --- including USA and countries of Austria, Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Dubai, England, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Korea, Lebanon, Mexico, Netherlands, New Zealand, Poland, Romania, Singapore, Slovakia, Spain, Switzerland and Ukraine.
• 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 = LZO