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U.S. Department of Health and Human Services

Class 2 Device Recall Stelkast Unicondylar Knee Femoral Component SC24621

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 Class 2 Device Recall Stelkast Unicondylar Knee Femoral Component SC24621see related information
Date Initiated by FirmMay 05, 2009
Date PostedNovember 20, 2009
Recall Status1 Terminated 3 on November 20, 2009
Recall NumberZ-0371-2010
Recall Event ID 53772
510(K)NumberK032824 
Product Classification Knee joint femorotibial metal/polymer non-constrained cemented prosthesis. - Product Code HSX
ProductStelkast Unicondylar Knee Femoral Component SC2462-1. Used for moderate joint impairment from painful arthritis (rheumatoid, osteo and/or post-traumatic; revision of failed unicompartmental knee implant or other procedure; and alternative to tibial osteotomy in patients with unicompartmental arthritis.
Code Information Lot number 20210-100108
FEI Number 3004142400
Recalling Firm/
Manufacturer		 Stelkast Co
200 Hidden Valley Rd
Mcmurray PA 15317-2659
For Additional Information ContactLinda Dunmire
724-941-6368
Manufacturer Reason
for Recall		incorrect size markings on component
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe recalling firm telephoned the medical supply companies on 5/5-19/09 to inform them of the problem and the need to return the products. If there are questions regarding this issue, please call 1.888.273.1583.
Quantity in Commerce20 units
DistributionNationwide
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 = HSX
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