• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Scorpio Total Knee Cruciate Retraining Femoral Component

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections

New Search Back to Search Results
 Class 3 Recall
Scorpio Total Knee Cruciate Retraining Femoral Component
see related information
Date Posted July 16, 2008
Recall Status1 Terminated on July 16, 2008
Recall Number Z-1381-2008
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 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/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
For Additional Information Contact Rita Intorella
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
Action Consignees were notified by letter on 2/8/05. For additional information contact 201-831-5825.
Quantity in Commerce 7 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.