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U.S. Department of Health and Human Services

Class 2 Device Recall Polyethylene Liner

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  Class 2 Device Recall Polyethylene Liner see related information
Date Initiated by Firm April 11, 2008
Date Posted September 05, 2008
Recall Status1 Terminated 3 on January 21, 2009
Recall Number Z-1789-2008
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, 64mm; Cat. #496-28-064; Sterile, Single Use; distributed by Encore Medical, L.P., Austin, TX 78758.
Code Information Lot/Serial #209472, 209482, 235192, 276652, 510961 and 964151.
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 2		 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 28 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.
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