BEUDAMED
    FDA Enforcement Class II Terminated

    RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)

    Recall: Z-1909-2017 · Reported May 10, 2017

    Enforcement

    Recall Number
    Z-1909-2017
    Event ID
    76943
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 10, 2017
    Initiation Date
    March 30, 2017
    Classification Date
    May 2, 2017
    Termination Date
    August 21, 2019
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804, United States

    Description

    RENOVATION, RADIAL OSTEOTOME BLADE, SIZE 10, REF 71369310, STERILE R, QTY: (1)

    Reason

    The stability data does not support the product labeled with a 10-year shelf life.

    Code Info

    Batch numbers: 431604,442526,448956,463451,469005,473044,477931,481940,488987,493639,494049,494154, 4357136931,4500034104,07MSY0014,08CSY0043,08CSY0050,08CSY0053,08CSY0053B,08JSY0007, 08LSY0012,08MSY0016,10CSY0006,10HSY0006,11DSY0003,11ESY0007,11FSY0008,11GSY0009, 11GSY0025,11JSY0010,11MSY0020,12ASY0012,12BSY0017,12CSY0006,12HSY0008,12HSY0038, 12KSY0029,12LSY0024,12MSY0024,13BSY0030,13BSY0031,13FSY0018,13FSY0020,13LSY0010, 13MSY0004,14ASY0002,14CSY0007,14CSY0036,14GSY0026,14LSY0011,15ASY0015,15DSY0013, 15FSY0015,15KSY0037,16ASY0007,16BSY0014,16GSY0022,463451A,469005B

    Distribution

    Nationwide and Australia, Austria, Belgium, Canada, China, Colombia, Costa Rica, Denmark, Estonia, Finland, France, Great Britain, India, Italy, Japan, Mexico, Netherlands, Norway, Poland, Puerto Rico, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, United Arab Emirates, and Venezuela

    Quantity

    1535 units