| Class 3 Device Recall Proven Knee Tibial Augmentation and Screw |  |
Date Initiated by Firm | October 05, 2007 |
Date Posted | January 23, 2008 |
Recall Status1 |
Terminated 3 on January 23, 2008 |
Recall Number | Z-0479-2008 |
Recall Event ID |
45528 |
510(K)Number | K051976 |
Product Classification |
Tibial Half Block with Screw - Product Code JWH
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Product | StelKast Proven Knee System - Tibial Half Block Augmentation and Screw. Part Number SC2287-1-5, Size 1, Thickness 5 mm, StelKast, Murray, PA 15317 |
Code Information |
Lot Numbers: 14888-122005, 16052-032706, and 18549-091807. |
Recalling Firm/ Manufacturer |
Stelkast Co 200 Hidden Valley Rd Mcmurray PA 15317-2659
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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 | 48 units |
Distribution | Nationwide: shipped to medical facilities in IL, NC, PA, TN, TX, VA, and WV. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = JWH
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