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U.S. Department of Health and Human Services

Class 2 Device Recall Keramos Ceramic/Ceramic Total Hip System

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  Class 2 Device Recall Keramos Ceramic/Ceramic Total Hip System see related information
Date Initiated by Firm June 08, 2005
Date Posted August 03, 2005
Recall Status1 Terminated 3 on April 19, 2007
Recall Number Z-1063-05
Recall Event ID 32301
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented - Product Code MRA
Product Keramos Ceramic Femoral Heads. Product consists of ceramic femoral head and liner used in hip replacement surgeries.
Code Information Catalog # 400-01-290/291/292/295/296/297 498-28-048
Recalling Firm/
Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
Manufacturer Reason
for Recall
Labeling on the Keramos Ceramic Femoral Heads and Liner indicates the product expiration date of 6 years instead of 5 years.
FDA Determined
Cause 2
Action The firm notified all sales agencies and affected products are on return.
Quantity in Commerce Nationwide including: TX, MS, FL, SC, GA, CA, PA, MA, NJ, MD, OK, MO, AZ, SD, UT, ID
Distribution Nationwide
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.