BEUDAMED
    FDA Recall Terminated

    Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy.

    Recall: Z-0793-2016 · Initiated January 11, 2016

    Recall

    Recall Number
    Z-0793-2016
    Event Number
    73084
    Firm
    Smith & Nephew, Inc.
    FEI Number
    3003604053
    Product Code
    NBH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    January 11, 2016
    Terminated
    September 18, 2017
    Address
    150 Minuteman Rd, Andover, MA, 01810-1031

    Description

    Smith & Nephew BEAVER Blade 4.0mm Part Number: 72203307 Orthopedic surgical instrument used in hip arthroscopy.

    Reason

    Blade exhibiting fracture during hip arthroscopy procedures

    Action

    Smith & Nephew issued letters via Federal Express on January 11, 2016. requested to inspect inventory and locate any unused devices and quarantine them immediately. Complete Inventory Return Certification Form on the following page, indicating the quantities that need to be returned. Contact Smith & Nephews Field Action Department via email at [email protected] or fax +1-901-566-7975 to obtain a return authorization (RA) number.

    Distribution

    Worldwide distribution. US Nationwide and countries of AT, AU, BE, CA, CH, CL, CN, CZ, DB, DE, DK, EE, ES, FI, FR, GB, HK, IE, IL, IN, IT, JP, LT, LV, NL, NO, PL, PR, PT, RO, SE, SG, SI, TH, TR, and ZA.

    Quantity

    69043 units