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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Alumina Ceramic Femoral Head

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  Class 2 Device Recall Zimmer Alumina Ceramic Femoral Head see related information
Date Initiated by Firm June 11, 2008
Date Posted November 21, 2008
Recall Status1 Terminated 3 on November 10, 2009
Recall Number Z-0304-2009
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, 32 mm diameter, neck length +3.5 mm, sterile, Zimmer, Warsaw, IN; REF 00-6418-032-03 and 00-6428-032-03.

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 2		 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 and Original Applicant = ZIMMER, INC.
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