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U.S. Department of Health and Human Services

Class 3 Device Recall Scorpio Total Knee Posteriorly Stabalized Femoral Component

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 Class 3 Recall
Scorpio Total Knee Posteriorly Stabalized Femoral Component
see related information
Date Posted July 16, 2008
Recall Status1 Terminated on July 16, 2008
Recall Number Z-1382-2008
Recall Event ID 47219
Premarket Notification
510(K) Numbers
K962152  K974556 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Scorpio Total Knee Posteriorly Stabilized Femoral Component; Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis; Product Number: 71-4507R; Stryker Corp, Howmedica Osteonics Corp, Mahwah, NJ 07430.
Code Information Lot Number: K04W718.
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
For Additional Information Contact Rita Intorella
201-831-5825
Manufacturer Reason
for Recall
Mislabeled: The labeling indicates a Scorpio PS Femoral Component, however, the device inside the package is actually a Scorpio CR Femoral Component.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Consignees were notified by letter on 2/8/05. For additional information contact 201-831-5825.
Quantity in Commerce 5 units
Distribution Worldwide Distribution including USA and countries of Canada, Mexico, Italy, The Netherlands and the UK.
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 = OSTEONICS CORP.
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