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U.S. Department of Health and Human Services

Class 2 Device Recall Tornier AFFINITI Humeral Head

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  Class 2 Device Recall Tornier AFFINITI Humeral Head see related information
Date Initiated by Firm October 20, 2008
Date Posted January 23, 2009
Recall Status1 Terminated 3 on May 07, 2011
Recall Number Z-0830-2009
Recall Event ID 50232
510(K)Number K060988  
Product Classification shoulder, prosthesis - Product Code KWS
Product Tornier AFFINITI Humeral Head Standard 48mm x 21mm, Catalog No. 0020050. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.
Code Information Lot No.: AA1293
Recalling Firm/
Manufacturer
Tournier, Inc.
Manufacturer Reason
for Recall
Tornier, Medical has received on report of a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of AFFINITI Stems.
FDA Determined
Cause 2
Labeling Change Control
Action An Urgent Product Recall letter, dated 10/17/08, was hand delivered to end users by distributors and sales representatives beginning 10/20/08. The recall letter identified the issue and requested end users to immediately discontinue use of the affected products and return any unused affected products to Tornier. Distributors were to notify any and all accounts that may be end users or to provide this information to Tornier, whom will contact the end users. A questionnaire and return instructions were provided with the letter. The questionnaire was asked to be completed and returned to Tornier as soon as possible. For additional information, contact Tornier Customer Service at 1-888-494-7950.
Quantity in Commerce 401 total
Distribution AR, CA, FL, NC, NE, OH, PA, TN, TX, WA, and WI
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 = DVO EXTREMITY SOLUTIONS, LLC
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