| Class 2 Device Recall Keramos Ceramic/Ceramic Total Hip System |  |
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
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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
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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 | 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 |
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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.
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