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U.S. Department of Health and Human Services

Class 2 Device Recall Dual Taper Wedge Pressed Fit Femoral Component

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 Class 2 Device Recall Dual Taper Wedge Pressed Fit Femoral Componentsee related information
Date Initiated by FirmOctober 07, 2008
Date PostedJanuary 28, 2009
Recall Status1 Terminated 3 on April 01, 2009
Recall NumberZ-0664-2009
Recall Event ID 50128
510(K)NumberK953268 
Product Classification hip prosthesis - Product Code LWJ
ProductStelkast Dual Taper Wedge Pressed Fit Femoral Component. Hip Prosthesis, Part number SC1439
Code Information Part number SC1439-1000. Lot number 17877-071707 exp 7/2017
Recalling Firm/
Manufacturer		 Stelkast Co
200 Hidden Valley Rd
Mcmurray PA 15317-2659
For Additional Information ContactJohn Litwin
888-273-1583
Manufacturer Reason
for Recall		Sterility may be compromised due to breach in packaging.
FDA Determined
Cause 2		Package design/selection
ActionOn 10/7/08, Stelkast telephoned the two customers of the problem and the need to return the products.
Quantity in Commerce6 units
DistributionUSA distribution to dealers in TX and WV.
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 = LWJ
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