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U.S. Department of Health and Human Services

Class 3 Device Recall Scorpio Total Knee Cruciate Retraining Femoral Component

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 Class 3 Device Recall Scorpio Total Knee Cruciate Retraining Femoral Componentsee related information
Date Initiated by FirmFebruary 08, 2005
Date PostedJuly 16, 2008
Recall Status1 Terminated 3 on July 16, 2008
Recall NumberZ-1381-2008
Recall Event ID 47219
510(K)NumberK974556 
Product Classification Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis - Product Code JWH
ProductScorpio Total Knee Cruciate Retraining Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 70-300-7R; Stryker Corp, Howmedica Osteonics Corp, Mahwah, NJ 07430.
Code Information Lot Number: K04W966.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information ContactRita Intorella
201-831-5825
Manufacturer Reason
for Recall		Mislabeled: The labeling indicates a Scorpio CR Femoral Component, however, the device inside the package is actually a Scorpio PS Femoral Component.
FDA Determined
Cause 2		Labeling mix-ups
ActionConsignees were notified by letter on 2/8/05. For additional information contact 201-831-5825.
Quantity in Commerce7 units
DistributionWorldwide Distribution including USA and countries of Canada, Mexico, Italy, The Netherlands and the UK.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JWH
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