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U.S. Department of Health and Human Services

Class 2 Device Recall Osteonics Scorpio Total Knee

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 Class 2 Recall
Osteonics Scorpio Total Knee
see related information
Date Posted September 16, 2008
Recall Status1 Terminated on September 24, 2008
Recall Number Z-2079-2008
Recall Event ID 48199
Premarket Notification
510(K) Number
K962152 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; #13 with posts, low friction Ion treatment. Use only with Scorpio Posteriorly Stabilized Tibial Bearing Components with Scorpio Patellar Components.
Code Information Catalog No. 711-4513L; Lot Code: K04S174
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
For Additional Information Contact Colleen O'Meara
201-831-5000
Manufacturer Reason
for Recall
Scorpio Posterior Stabilized Femoral Component labeled and laser marked as a Left, was in fact a Right component.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action The International Stryker Distributor was notified via an advisory notice with return receipt on March 18, 2005.
Quantity in Commerce 1 unit
Distribution The one unit was distributed to an International Stryker branch.
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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