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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Trilogy

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 Class 2 Recall
Zimmer Trilogy
see related information
Date Posted November 21, 2012
Recall Status1 Terminated on April 18, 2014
Recall Number Z-0416-2013
Recall Event ID 63541
Premarket Notification
510(K) Number
K934765 
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented - Product Code LPH
Product The Trilogy Acetabular System Shell with Cluster Holes Porous 56 mm O.D. Sterile The Trilogy Acetabular System is indicated for either cemented or uncemented use In skeletally mature Individuals undergoing primary or revision surgery for rehabilitating hips damaged as a result of noninflammatory degenerative joint disease (NIDJD) or its composite diagnoses of osteoarthritis, avascular necrosis, protrusio acetabuli, traumatic arthritis, slipped capital epiphysis, fused Hip, fracture of the pelvis, and diastrophic variant. The shells with screw holes permit the use of titanium alloy screws to provide additional fixation and security, particularly in those cases where acetabular bone stock is deficient.
Code Information REF 6200-056-22, lot 62010615
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746
For Additional Information Contact Dawn Kindle
574-372-4807
Manufacturer Reason
for Recall
Zimmer Trilogy¿ Acetabular System Shell with Cluster Holes, Porous,56 MM O.D., sterile; is missing polar hole threads. Zimmer received one complaint in which no injury was reported.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Zimmer sent a Urgent Medical Device Recall Notice dated September 20, 2012, to all affected customers. The letter identified the products the problem and the action needed to be taken by the customer. Customers were instructed to locate quarantine and return affected product to Zimmer Product Service Department, 1777 West center St. Warsaw, IN 46580 for product in the USA. Customers were asked to complete the Inventory Return Certification Form and follow the instructions where to return this form. For further questions please call (574) 372-4807.
Quantity in Commerce 24 USA; 71 worldwide
Distribution Worldwide Distribution--USA (nationwide) including the states of AL, CA, CT, KS, MA, MD, MN, MO, NY, SD, TX and WI and the countries of Bulgaria,Canada, Germany, Italy, Netherlands, Russian Fed, Sweden and UK
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = ZIMMER, INC.
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