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U.S. Department of Health and Human Services

Class 3 Device Recall Proven Knee Tibial Augmentation and Screw

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 Class 3 Recall
Proven Knee Tibial Augmentation and Screw
see related information
Date Posted January 23, 2008
Recall Status1 Terminated on January 23, 2008
Recall Number Z-0481-2008
Recall Event ID 45528
Premarket Notification
510(K) Number
K051976 
Product Classification Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
Product StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-3-5, Size 3, Thickness 5 mm, StelKast, Murray, PA 15317
Code Information Lot Numbers: 14892-122005, 16156-032706, and 17943-091807.
Recalling Firm/
Manufacturer
Stelkast Co
200 Hidden Valley Rd
Mcmurray, Pennsylvania 15317-2659
For Additional Information Contact John J. Litwin
724-941-6368
Manufacturer Reason
for Recall
The screws may fracture
FDA Determined
Cause 2
DESIGN: Device Design
Action The recalling firm telephoned their customers on 10/5/07 to inform them of the problem and the need to return the product. As a follow up to the telephone calls, the recalling firm issued a recall letter (Field Notification) on 10/9/07 via certified mail.
Quantity in Commerce 41 units
Distribution Nationwide: shipped to medical facilities in IL, NC, PA, TN, TX, VA, and WV.
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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