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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 Device Recall Proven Knee Tibial Augmentation and Screw see related information
Date Initiated by Firm October 05, 2007
Date Posted January 23, 2008
Recall Status1 Terminated 3 on January 23, 2008
Recall Number Z-0480-2008
Recall Event ID 45528
510(K)Number K051976  
Product Classification Tibial Half Block with Screw - Product Code JWH
Product StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number SC2287-2-5, Size 2 Thickness 5 mm, StelKast, Murray, PA 15317
Code Information Lot Numbers: 14890-111605, 17084-110706, and 17942-091807.
Recalling Firm/
Manufacturer		 Stelkast Co
200 Hidden Valley Rd
Mcmurray PA 15317-2659
For Additional Information Contact John J. Litwin
724-941-6368
Manufacturer Reason
for Recall		 The screws may fracture
FDA Determined
Cause 2		 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 38 units
Distribution Nationwide: shipped to medical facilities in IL, NC, PA, TN, TX, VA, 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 = JWH and Original Applicant = STELKAST COMPANY
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