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U.S. Department of Health and Human Services

Class 2 Device Recall SC2316, Distal Femoral Augment with Screw

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 Class 2 Device Recall SC2316, Distal Femoral Augment with Screwsee related information
Date Initiated by FirmJune 24, 2013
Date PostedSeptember 03, 2013
Recall Status1 Terminated 3 on October 08, 2014
Recall NumberZ-2136-2013
Recall Event ID 65823
510(K)NumberK021908 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductSC2316, Distal Femoral Augment with Screw Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis and/or post-traumatic degenerative problems and revision of failed previous reconstructions.
Code Information Part number SC2316-3-5 with lot number 22389-111609. Part number SC2316-4-5 with lot number 22587-111609. Part number SC2316-5-5 with lot number 23214-111609.
Recalling Firm/
Manufacturer		 Stelkast Co
200 Hidden Valley Rd
Mcmurray PA 15317-2659
For Additional Information ContactStelkast Customer Service
724-941-6368
Manufacturer Reason
for Recall		The firm became aware of an incident relating to a breach of sterility in the sterility barrier packaging of SC2316, Distal Femoral Augment with Screw.
FDA Determined
Cause 2		Process control
ActionStelkast called and emailed all customers on June 24, 2013, to notify them of the recall. Customers were asked to recover all affected products from their inventory and return them to Stelkast. Customers were instructed to contact Stelkast Customer Service for a Return Authorization (RA) Number prior to shipment to Stelkast. Customers with questions were instructed to call 1-888-273-1583. For questions regarding this recall call 724-941-6368.
Quantity in Commerce11
DistributionNationwide Distribution including TX, VA, OK, and PA
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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