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U.S. Department of Health and Human Services

Class 2 Device Recall Smith & Nephew

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  Class 2 Device Recall Smith & Nephew see related information
Date Initiated by Firm April 30, 2015
Date Posted June 22, 2015
Recall Status1 Terminated 3 on September 19, 2017
Recall Number Z-1822-2015
Recall Event ID 71257
510(K)Number K132079  
Product Classification Suture, nonabsorbable, synthetic, polyethylene - Product Code GAT
Product ULTRA-FAST FIX Knot Pusher Suture Cutters
Product Number: 72201537

Intended for Meniscal Repair.
Code Information All batches manufactured from April 2010 to April 2014 which have corresponding expiration dates of April 2015 to April 2019
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
150 Minuteman Rd
Andover MA 01810-1031
For Additional Information Contact
978-749-1000
Manufacturer Reason
for Recall		 Sterility of device maybe compromised
FDA Determined
Cause 2		 Package design/selection
Action Smith & Nephew sent an Urgent - Product Recall 1st Notification letter dated April 27, 2015, via Federal Express on April 30, 2015. Users are requested to inspect inventory and locate any unused devices from the above listed product and batch numbers, and quarantine them immediately. Complete the the Inventory Return Certification and obtain a RGA and obtain replacement product. Contact Smith & Nephews Field Action Department via email at FieldActions@smith-nephew.com or fax +1-901-566-7975 to obtain a return authorization (RA) number
Quantity in Commerce 202,279 units
Distribution Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : Argentina, Austria, Australia, Belgium, Brazil, Canada, Switzerland, Chile, China, Colombia, Costa Rica, Dubia UAE, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Guam, Hong Kong, Israel, India, Italy, Japan, Korea, Mexico, Malaysia, Netherlands, Norway, Portugal, Qatar, Sweden, Singapore,Thailand, Turkey, Taiwan, Venezuela and South Africa.
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 = GAT and Original Applicant = SMITH & NEPHEW, INC.
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