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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 Component see related information
Date Initiated by Firm October 07, 2008
Date Posted January 28, 2009
Recall Status1 Terminated 3 on April 01, 2009
Recall Number Z-0664-2009
Recall Event ID 50128
510(K)Number K953268  
Product Classification hip prosthesis - Product Code LWJ
Product Stelkast 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 Contact John Litwin
888-273-1583
Manufacturer Reason
for Recall
Sterility may be compromised due to breach in packaging.
FDA Determined
Cause 2
Package design/selection
Action On 10/7/08, Stelkast telephoned the two customers of the problem and the need to return the products.
Quantity in Commerce 6 units
Distribution USA distribution to dealers in TX and WV.
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 = LWJ and Original Applicant = STELKAST COMPANY
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