BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0793-2016 · Reported February 17, 2016

    Enforcement

    Recall Number
    Z-0793-2016
    Event ID
    73084
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 17, 2016
    Initiation Date
    January 11, 2016
    Classification Date
    February 10, 2016
    Termination Date
    September 18, 2017
    Address
    150 Minuteman Rd, N/A, Andover, MA, 01810-1031, United States

    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

    Code Info

    Lot Codes: ( Devices within Expiry) 3009063 3009559 3010117 3010720 3011688 3012095 3012366 3014560 3016455 3018390 3020194 3022929 3025736 3027818 3030178 3032892 3036529 3071312 3071546 3074279 3074280 3076377 3076427 3085969 3089220 3093258 3098516 3101929 3104300 3107341 3111387 3114657 3115976 3119607 3123832 3124356 3124896 3125448 3128384

    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