Class 2 Device Recall Polyethylene Liner

• Date Initiated by Firm: April 11, 2008
• Date Posted: September 05, 2008
• Recall Status: Terminated on January 21, 2009
• Recall Number: Z-1786-2008
• Recall Event ID: 47870
• Product Classification: Prosthesis, hip, semi-constrained, metal/ceramic/ceramic/metal, cemented or uncemented - Product Code MRA
• Product: Keramos Replacement Polyethylene Liner, 52mm; Cat. #496-28-052; Sterile, Single Use; distributed by Encore Medical, L.P., Austin, TX 78758.
• Code Information: Lot/Serial #209412, 209422, 235172, 276622, 467701 and 964121.
• FEI Number: 1000116912
• Recalling Firm/ Manufacturer: Encore Medical, Lp; 9800 Metric Blvd; Austin TX 78758
• For Additional Information Contact: 512-832-9500
• Manufacturer Reason for Recall: Keramos Replacement Polyethylene Liner used as a replacement for the Keramos ceramic liner in revision hip replacement surgeries marketed without 510(k) approval.
• FDA Determined Cause: Other
• Action: An Urgent: Medical Device Recall letter was issued by the firm on 04/11/08. Consignees were told that they did not have marketing approval for the Polyethylene Backup Liner (poly liner) for use with the Keramos Ceramic-on-Ceramic Acetabular System. Therefore, they are removing it from the market while pursuing marketing approval.
• Quantity in Commerce: 41 units
• Distribution: Class II Recall - Nationwide --- including the following states: AZ, CA, FL, MA, MO, NV, SC, SD and TX.
• 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.