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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 Device Recall Duracon Total Knee Modular Femoral see related information
Date Initiated by Firm October 17, 2006
Date Posted September 21, 2007
Recall Status1 Terminated 3 on July 07, 2009
Recall Number Z-1241-2007
Recall Event ID 38814
510(K)Number K920034  
Product Classification Knee Femoral Component - 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 NJ 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.
FDA Determined
Cause 2		 Other
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 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 = JWH and Original Applicant = PFIZER HOSPITAL PRODUCTS GROUP, INC.
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