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U.S. Department of Health and Human Services

Class 2 Device Recall DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS

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 Class 2 Recall
DURACON TOTAL KNEE SYSTEM TIBIAL COMPONENTS
see related information
Date Posted July 07, 2009
Recall Status1 Terminated on July 07, 2009
Recall Number Z-1601-2009
Recall Event ID 50093
Premarket Notification
510(K) Number
K915512 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Duracon Total Knee, A-P Lipped Tibial Insert; 11MM Sterile; Howmedica Osteonics Corp. Stryker, Ireland. Product No. 6642-1-611. The device is used to replace bearing surface if the proximal tibia in order to relieve pain, instability and/or restriction of motion due to degenerative joint disease, failed previous prosthesis or trauma. The tibial inserts are designed to accommodate the posterior cruciate ligament if it is present. These components are intended for implantation with bone cement only.
Code Information Lot Code: 17800601.
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430
For Additional Information Contact Rita Intorella
201-831-5000
Manufacturer Reason
for Recall
A box packaged and labeled as a Duracon Total Knee Duration A-P Lipped Tibial Insert 11MM may actually contain a 9MM insert.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action A notification letter and product accountability form were sent via Federal Express on May 5, 2006 with return receipt to branch accounts that had received the affected product. For questions about the recall contact Stryker Howmedica Osteonics Corp. by calling 1-201-831-5000.
Quantity in Commerce 8
Distribution Nationwide Distribution (AL, OH, MN, NM, and CA).
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = PFIZER HOSPITAL PRODUCTS GROUP, INC.
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