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U.S. Department of Health and Human Services

Class 2 Device Recall Turon Humeral Head Trials

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  Class 2 Device Recall Turon Humeral Head Trials see related information
Date Initiated by Firm November 05, 2010
Date Posted December 22, 2010
Recall Status1 Terminated 3 on April 05, 2011
Recall Number Z-0798-2011
Recall Event ID 57210
510(K)Number K080402  
Product Classification orthopedic instrument - Product Code KWS
Product Turon Shoulder System Instrumentation, Turon Humeral Head Trials, DJO Surgical
Code Information Part numbers: 804-05-021, 804-05-022, 804-05-023, 804-05-024, 804-05-025, 804-05-026, 804-05-027, 804-05-028, 804-05-029, 804-05-030, 804-05-031, 804-05-032, 804-05-033, 804-05-034,  804-05-035, 804-05-036, 804-05-037, 804-05-038, 804-05-039, 804-05-040, 804-05-041, 804-05-042, 804-05-043, 804-05-044, 804-05-045
Recalling Firm/
Manufacturer		 Encore Medical, Lp
9800 Metric Blvd
Austin TX 78758
For Additional Information Contact
512-832-9500
Manufacturer Reason
for Recall		 Complaints of fracturing were reported for trial products.
FDA Determined
Cause 2		 Device Design
Action Encore Medical notified consignees by letter on 11/5/2010.
Quantity in Commerce 425 units
Distribution TX, FL, SC, GA
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 = KWS and Original Applicant = ENCORE MEDICAL, L.P.
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