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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = GAT
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