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U.S. Department of Health and Human Services

Class 2 Device Recall JETX(R) 6 MM X 45 MM SHORT HALF PIN TI6AL4V

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  Class 2 Device Recall JETX(R) 6 MM X 45 MM SHORT HALF PIN TI6AL4V see related information
Date Initiated by Firm April 13, 2012
Date Posted June 06, 2012
Recall Status1 Terminated 3 on September 22, 2015
Recall Number Z-1753-2012
Recall Event ID 61767
510(K)Number K994143  
Product Classification Pin, fixation, threaded - Product Code JDW
Product JET-X(R) 6 MM X 45 MM SHORT HALF PIN TI-6AL-4V, REF 71056458, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116

Orthopedic surgical device.
Code Information Lot Numbers: 09FM20572, 09KM13396, 10FM17769, 11AM08284, 11FM01375, 11FM18512, 11FM18513, 11MM09410, 11MM09412 
Recalling Firm/
Smith & Nephew Inc
1450 E. Brooks Rd
Memphis TN 38116
For Additional Information Contact Joe Metzger
Manufacturer Reason
for Recall
Plastic trays which encase these products have burrs on the hinged packaging which can puncture the single barrier sterile pouch, voiding sterility.
FDA Determined
Cause 2
Action Smith & Nephew Sales Representatives and Smith & Nephew International Distributors were notified of the problem with the affected product and the recall via email on April 13, 2012. All affected direct consignees were notified via Fed Ex on April 13, 2012. The Urgent Medical Device Recall letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to cease use and distribution of the product and quarantine them immediately for return. Customers were instructed to complete the Inventory Return Certification Form included with the letter. Customers should fax or email the form to 901-566-7975 or fieldactions@smith-nephew.com. The affected product should be returned to: Smith & Nephew Attn: Global Field Actions Safety Affairs 1450 Brooks Road Memphis, Tennessee 38116 If the affected product was distributed further customers were instructed to provide a copy of the recall letter to these customers.
Quantity in Commerce 176 units
Distribution Worldwide Distribution - USA (nationwide) and the countries of Australia, Malaysia, Germany, Japan, Portugal, United Arab Emirates, Spain, France, South Africa, Norway, Sweden, Denmark, Switzerland, Belgium, China, The Netherlands, Finland, Mexico, Italy, UK, Venezuela, Colombia, Thailand, Chile, South Korea, India, and Turkey
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 = JDW and Original Applicant = SMITH & NEPHEW, INC.