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U.S. Department of Health and Human Services

Class 2 Device Recall Scorpio NRG

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  Class 2 Device Recall Scorpio NRG see related information
Date Initiated by Firm August 20, 2007
Date Posted March 16, 2010
Recall Status1 Terminated 3 on March 16, 2010
Recall Number Z-1141-2010
Recall Event ID 50102
510(K)Number K030978  
Product Classification knee prosthesis - 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/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information Contact Rich Wolyn
201-831-5158
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		 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 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) Database 510(K)s with Product Code = JWH and Original Applicant = HOWMEDICA OSTEONICS CORP.
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