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U.S. Department of Health and Human Services

Class 2 Device Recall Scorpio PS Femoral Waffle and LFIT

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  Class 2 Device Recall Scorpio PS Femoral Waffle and LFIT see related information
Date Initiated by Firm July 30, 2007
Date Posted February 19, 2010
Recall Status1 Terminated 3 on February 19, 2010
Recall Number Z-0795-2010
Recall Event ID 50101
510(K)Number K962152  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Scorpio PS Femoral Waffle (No post) and LFIT; Use only with Scorpio PS Tibial Bearing inserts and Scorpio Patellas, Stryker Orthopaedics.

Intended for cemented application to replace the articulating surface of the distal femur.
Code Information Scorpio (no post) with LFIT: Product code 72-4107-L; Lot code: JKWMHD; 
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430
For Additional Information Contact Rita Intorella
201-831-5825
Manufacturer Reason
for Recall		 Stryker Orthopaedics became aware that a box packaged and labeled as a Scorpio PS Femoral Waffle (No Post) with LFIT, may actually contain a Scorpio Femoral Waffle (With Post) and LFIT.
FDA Determined
Cause 2		 Labeling mix-ups
Action Stryker Orthopaedics issued an "Important Product Removal" letter via Federal Express dated July 30, 2007 to all direct accounts. Users were asked to identify and return all affected product to the firm. For further information, contact Stryker Orthopaedics at (201) 831-5825.
Quantity in Commerce 7
Distribution Worldwide Distribution -- United States and 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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