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U.S. Department of Health and Human Services

Class 2 Device Recall Total Knee Posteriorly Stabilized Femoral Component

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 Class 2 Device Recall Total Knee Posteriorly Stabilized Femoral Componentsee related information
Date Initiated by FirmNovember 08, 2005
Date PostedSeptember 11, 2008
Recall Status1 Terminated 3 on May 13, 2010
Recall NumberZ-1814-2008
Recall Event ID 48096
510(K)NumberK962152 
Product Classification Knee Stabilizer - Product Code KWY
ProductScorpio Total Knee Posteriorly Stabilized Femoral Component, #7R, Catalog No.: 71-4107R, Lot Code: K05L310; Scorpio Total Knee Posteriorly Stabilized Femoral Component, #7L, Catalog No. 71-4506L, Lot Code K05L224.
Code Information Catalog No: 71-4107R, Lot Code: K05L310; Catalog No: 71-4506L, Lot Code K05L224
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2002
For Additional Information ContactLawrence Ross
201-831-5000
Manufacturer Reason
for Recall		Mislabeled boxes -- Scorpio PS Right Femoral Component No Posts contained a Scorpio PS Left Femoral Component with Posts and vice versa.
FDA Determined
Cause 2		Employee error
ActionConsignees were notified by letter sent via Federal Express with return receipt on November 8, 2005. All consginees who received the subject devices were provided Product Accountability forms to be returned to the firm.
Quantity in Commerce8 units
DistributionWorldwide Distribution
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 = KWY
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