BEUDAMED
    FDA Recall Terminated

    Arthrex Suture Washer

    Recall: Z-2918-2016 · Initiated August 12, 2016

    Recall

    Recall Number
    Z-2918-2016
    Event Number
    75050
    Firm
    Arthrex, Inc.
    FEI Number
    1220246
    Product Code
    HTN
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 12, 2016
    Terminated
    August 20, 2019
    Address
    1370 Creekside Blvd, Naples, FL, 34108-1945

    Description

    Arthrex Suture Washer

    Reason

    The device was assembled incorrectly. Suture and washer were not assembled; components were placed loose in the package.

    Action

    Consignees were notified 8/12/2016 of the potentially affected devices; Product/Batch Numbers: AR-7000-818T Batch #10028617. For Healthcare Professionals: immediately discontinue use of all affected products with stated numbers in their possession. Call (855) 552-5056 or email [email protected] with the product number, lot, and quantities so they may ship replacement products and expedite return of recalled product. To please complete the "Recall Acknowledgement of Receipt: postal card and return to Arthrex, Inc. Distributing Agencies: Immediately identify and hold all stated products in your inventory. Call 888-519-7255 ext. 72067 or e-mail [email protected] Attn: Christi Zimmer. Have product number, lot number and quantities you may have so replacement product may be shipped and expedite the return of the recalled product. Please complete the "Recall Acknowledgement of Receipt" postal card and return to Arthrex. Inc. Any questions about the return of products to call 866-267-9138 and ask for Ellen Barry. Also by email to [email protected].

    Distribution

    OR, NY, MN, KY, CA, ID, CO, MA, and FL. Thailand.

    Quantity

    45 devices