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Class 3 Device Recall Proven Knee Tibial Augmentation and Screw |
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Date Initiated by Firm |
October 05, 2007 |
Date Posted |
January 23, 2008 |
Recall Status1 |
Terminated 3 on January 23, 2008 |
Recall Number |
Z-0483-2008 |
Recall Event ID |
45528 |
510(K)Number |
K051976
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Product Classification |
Tibial Half Block with Screw - Product Code JWH
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Product |
StelKast Proven Knee - Tibial Half Block Augmentation and Screw. Part Number: SC2287-5-5, Size 5, Thickness 5 mm, StelKast, Murray, PA 15317 |
Code Information |
Lot Numbers: 14896-122005, 16042-010906, 16048-031406, 16056-031406, and 16157-031406. |
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
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Manufacturer Reason for Recall |
The screws may fracture
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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 |
34 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 and Original Applicant = STELKAST COMPANY
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