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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 LFITsee related information
Date Initiated by FirmJuly 30, 2007
Date PostedFebruary 19, 2010
Recall Status1 Terminated 3 on February 19, 2010
Recall NumberZ-0795-2010
Recall Event ID 50101
510(K)NumberK962152 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductScorpio 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 ContactRita 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
ActionStryker 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 Commerce7
DistributionWorldwide Distribution -- United States and France.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JWH
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