Class 2 Device Recall Keramos Ceramic/Ceramic Total Hip System

• Date Initiated by Firm: June 08, 2005
• Date Posted: August 03, 2005
• Recall Status: Terminated 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/ Manufacturer: 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: Other
• 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.