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U.S. Department of Health and Human Services

Class 2 Device Recall Scorpio

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  Class 2 Device Recall Scorpio see related information
Date Initiated by Firm August 11, 2005
Date Posted October 15, 2005
Recall Status1 Terminated 3 on August 15, 2007
Recall Number Z-0058-06
Recall Event ID 33035
510(K)Number K974556  
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product Scorpio Total Knee Cruciate Retaining Femoral Component, #7, left, Catalog No. 70-4107L. Manuf. by Stryker Orthopaedics, Mahwah, NJ, 1 each to a package.
Code Information Catalog No: 70-4107L Lot Code: K04W537
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information Contact Dominick Cristofolo
201-831-5247
Manufacturer Reason
for Recall		 The Left Scorpio Total Knee Cruciate Retaining Waffle Femoral Component #7 packaged and labeled as left may contain a Right and vice versa.
FDA Determined
Cause 2		 Other
Action The recall notification was sent out via FedEx on 8/11/2005 with requested return receipt.
Quantity in Commerce 8 units
Distribution The product was distributed to their sales representatives/sales agencies, hospitals, and international distribution. The product was shipped to Stryker Germany and Stryker France.
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 = OSTEONICS CORP.
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