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U.S. Department of Health and Human Services

Class 2 Device Recall Scorpio NRG

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 Class 2 Recall
Scorpio NRG
see related information
Date Posted March 16, 2010
Recall Status1 Terminated on March 16, 2010
Recall Number Z-1141-2010
Recall Event ID 50102
Premarket Notification
510(K) Number
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Howmedica Osteonics Corp., Scorpio NRG Femoral Size 7 Right; Knee prosthesis (Stryker France). Product Code: 814407R. Mahwah, NJ
Code Information Product Code: 814407R; Lot Code: L65MKD
Recalling Firm/
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430
For Additional Information Contact Rich Wolyn
Manufacturer Reason
for Recall
A box labeled as a Scorpio NRG Femoral Size 7 Right, may actually contain a Scorpio PS Femoral Size 5 Right.
FDA Determined
Cause 2
DESIGN: Process Design
Action Stryker Important Product Removal Letters were sent via Federal Express on 8/20/2007.
Quantity in Commerce 4 units
Distribution Product went to 2 US Stryker branches.
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 = HOWMEDICA OSTEONICS CORP.