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Class 2 Device Recall Turon Trial Humeral Neck |
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Date Initiated by Firm |
November 05, 2010 |
Date Posted |
December 22, 2010 |
Recall Status1 |
Terminated 3 on April 05, 2011 |
Recall Number |
Z-0799-2011 |
Recall Event ID |
57210 |
510(K)Number |
K080402
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Product Classification |
orthopedic instrument - Product Code KWS
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Product |
Turon Shoulder System Instrumentation, Turon Trial Humeral Neck, DJO Surgical |
Code Information |
Part number 804-15-000, and 804-15-001 |
Recalling Firm/ Manufacturer |
Encore Medical, Lp 9800 Metric Blvd Austin TX 78758
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For Additional Information Contact |
512-832-9500
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Manufacturer Reason for Recall |
Complaints of fracturing were reported for affected trial products.
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FDA Determined Cause 2 |
Device Design |
Action |
Encore Medical notified consignees by letter on 11/5/2010. |
Quantity in Commerce |
34 units |
Distribution |
TX, FL, SC, GA |
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 = KWS and Original Applicant = ENCORE MEDICAL, L.P.
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