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U.S. Department of Health and Human Services

Class 2 Device Recall Trilogy Acetabular AB Shells with Holes

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 Class 2 Recall
Trilogy Acetabular AB Shells with Holes
see related information
Date Posted February 04, 2013
Recall Status1 Open
Recall Number Z-0776-2013
Recall Event ID 63531
Premarket Approval
PMA Number
P040048
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented - Product Code MRA
Product Trilogy Acetabular AB Shells with Holes. The Trilogy Acetabular System is indicated for either cemented or uncemented use in individuals undergoing surgery for rehabilitating hip damage.
Code Information 62054788 61901417 61984072 61901423 61901426 61901427 61901428 61901435 61901437 61278096
Recalling Firm/
Manufacturer
Zimmer, Inc.
345 E Main St
Warsaw, Indiana 46580-2746
For Additional Information Contact Jaime L. Weeks
574-372-4807
Manufacturer Reason
for Recall
Some units of Trilogy shells manufactured since March 2009 may be below the lower range of the pore size specification (as low as 28% vs. 30% porosity specification). On 10/31/2012, the firm expanded the recall action to include lots of Uni-Hole Trilogy Acetabular System shells.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Zimmer sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated September 20, 2012 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.The firm expanded the scope of the recall in January 2013 to include devices that use a secondary mean of fixation. New recall letters will be submitted to distributors and surgeons.
Quantity in Commerce 275,952 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of Denmark, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Spain, Sweden, UK, Poland, France, Australia, Chile, Canada, India, Japan, New Zealand, Peru, South Africa, Colombia, Ukraine, and UAE.
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.
PMA Database PMAs with Product Code = MRA and Applicant = ZIMMER, INC.
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