BEUDAMED
    FDA Recall Terminated

    ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625

    Recall: Z-0714-2007 · Initiated February 1, 2007

    Recall

    Recall Number
    Z-0714-2007
    Event Number
    37358
    Firm
    Integra Biotechnical LLC
    FEI Number
    1000519289
    Product Code
    FRO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 1, 2007
    Posted
    April 4, 2007
    Terminated
    August 3, 2012
    Address
    2755 Dos Aarons Way, Ste B, Vista, CA, 92081

    Description

    ProWick Shoulder Postoperative Dressing and Cold Therapy System, Model number AR-1625

    Reason

    During routine new product testing, it was discovered that the product may not be sterile, although sterilized in accordance with validated parameters.

    Action

    An email and/or fax recall notification was sent starting on 02/1/2007 by Arthrex, Inc. (the Primary Distributor) . A product recall notice in the form of a letter was mailed via US Postal Certified Mail, return receipt requested by Arthrex, Inc. to all of the Distributor''s customers starting on 02/1/2007, including those who have not ordered or received the Recalled Product. Customers were asked to 'segregate and protect the product from shipment, and return all unused products to Arthrex, Inc.'

    Distribution

    Nationwide

    Quantity

    1769