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U.S. Department of Health and Human Services

Class 3 Device Recall Duracon Total Knee Modular Femoral

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 Class 3 Recall
Duracon Total Knee Modular Femoral
see related information
Date Posted September 21, 2007
Recall Status1 Terminated on July 07, 2009
Recall Number Z-1241-2007
Recall Event ID 38814
Premarket Notification
510(K) Number
K920034 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Duracon Total Knee Modular Femoral Component; Non-Porous Right Medium Assembly, Product No. 6632-0-325
Code Information Product No. 6632-0-325; Lot code UCVO
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
For Additional Information Contact Larry Ross
201-831-5972
Manufacturer Reason
for Recall
Loose fixation pegs: One lot of femoral components may have loose fixation pegs.
Action Notification letters, dated 10/17/2006, were sent via Federal Express on 10/17/2006 to all consignees requesting return of product.
Quantity in Commerce 3 total, 2 in USA
Distribution Worldwide : One Hospital in Georgia (USA), Stryker Branch in Indiana and Stryker Branch in Sweden.
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
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = PFIZER HOSPITAL PRODUCTS GROUP, INC.
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