Class 3 Device Recall Keramos CeramiconCeramic Acetabular System

• Date Initiated by Firm: January 12, 2006
• Date Posted: April 27, 2006
• Recall Status: Terminated 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/ Manufacturer: 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: Other
• 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.