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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 October 14, 2010
Date Posted November 18, 2010
Recall Status1 Terminated 3 on May 09, 2012
Recall Number Z-0419-2011
Recall Event ID 57041
510(K)Number K092508  
Product Classification Nonabsorbable Polyethylene Synthetic Suture - Product Code GAT
Product Smith & Nephew FAST FIX 360, STRAIGHT NEEDLE
Catalog Number; 72202467.

Intended for use as a suture retention device to facilitate percutaneous or endoscopic soft tissue procedures such as shoulder stabilization (Bankart Repair), rotator cuff repair, meniscal repair, and gastrostomy.
Code Information Lot Numbers: 50327432 and 50329735.
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
For Additional Information Contact Same
978-749-1073
Manufacturer Reason
for Recall		 FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation.
FDA Determined
Cause 2		 Device Design
Action Smith & Nephew notified customers by an Urgent - Product Recall 1st Notification - Urgent letter sent via Federal Express October 14, 2010. The letter identified the affected product and explained the problem. The letter asked customers to call for a Return Authorization (RA) Number. Customers are to complete the form and return of the affected product along with a copy of the letter to the address provided being sure to reference the RA number. Questions were to be directed to Cindy Burns at 508-261-3655. Consignees out side the US were notified by e-mail.
Quantity in Commerce 53 units
Distribution Worldwide Distribution - USA, Dubai, and Great Britain.
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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