BEUDAMED
    FDA Recall Terminated

    Smith & Nephew FAST FIX 360, REVERSE CURVED NEEDLE Catalog Number; 72202469. 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.

    Recall: Z-0421-2011 · Initiated October 14, 2010

    Recall

    Recall Number
    Z-0421-2011
    Event Number
    57041
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    FEI Number
    3003604053
    Product Code
    GAT
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 14, 2010
    Posted
    November 18, 2010
    Terminated
    May 9, 2012
    Address
    150 Minuteman Drive, Andover, MA, 01810-1031

    Description

    Smith & Nephew FAST FIX 360, REVERSE CURVED NEEDLE Catalog Number; 72202469. 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.

    Reason

    FasT-Fix 360 Needle Delivery System may not allow the T-2 (anchor) to advance for implantation.

    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.

    Distribution

    Worldwide Distribution - USA, Dubai, and Great Britain.

    Quantity

    130 units