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U.S. Department of Health and Human Services

Class 3 Device Recall Keramos CeramiconCeramic Acetabular System

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  Class 3 Device Recall Keramos CeramiconCeramic Acetabular System see related information
Date Initiated by Firm January 12, 2006
Date Posted April 27, 2006
Recall Status1 Terminated 3 on July 11, 2006
Recall Number Z-0799-06
Recall Event ID 34416
510(K)Number K950542  
Product Classification Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented - Product Code LPH
Product Porous titanium flared rim acetabular shell with three clustered holes in even sizes from 48 to 66mm, a hip prosthesis component. The lot number on the product labeling is the unique identifier of this component.
Code Information Lot numbers 276202 and 270512
Recalling Firm/
Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
Manufacturer Reason
for Recall
Voids in the porous coating of a component used in total hip replacement surgery.
FDA Determined
Cause 2
Action Firm notified all sales agents by letter on January 12, 2006 with instructions to return the product. The second letters went out on January 30, 2006 to the sales associates with instructions to contact the implanting physicians.
Quantity in Commerce Total of 30 units
Distribution Nationwide. Iowa, Florida, California, Arizona, South Dakota, Utah, Missouri, Texas, and Massachusetts, Maryland, Oklahoma, Nevada
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.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = ENCORE ORTHOPEDICS, INC.