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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 Recall
SC2316, Distal Femoral Augment with Screw
see related information
Date Posted September 03, 2013
Recall Status1 Terminated on October 08, 2014
Recall Number Z-2136-2013
Recall Event ID 65823
Premarket Notification
510(K) Number
K021908 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product SC2316, 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, Pennsylvania 15317-2659
For Additional Information Contact Stelkast 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
PRODUCTION CONTROLS: Process Control
Action Stelkast 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 Commerce 11
Distribution Nationwide Distribution including TX, VA, OK, and PA
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = JWH and Original Applicant = STELKAST COMPANY
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