BEUDAMED
    FDA Enforcement Class II Terminated

    Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck fractures; osteomyelitis; fracture, dislocation of the hip; and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection.

    Recall: Z-1066-2014 · Reported March 5, 2014

    Enforcement

    Recall Number
    Z-1066-2014
    Event ID
    67404
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 5, 2014
    Initiation Date
    January 23, 2014
    Classification Date
    February 21, 2014
    Termination Date
    November 15, 2016
    Address
    1450 E. Brooks Rd, Memphis, TN, 38116, United States

    Description

    Reflection Interfit Shell, 52 MM OD, 3 HOLE, REF 71336052, QTY 1, STERILE R, Smith & Nephew, Inc. Indications for use include cemented or uncemented total hip arthroplasty for rheumatoid arthritis; osteoarthritis; post traumatic arthritis, avascular necrosis; femoral and neck fractures; osteomyelitis; fracture, dislocation of the hip; and unsuccessful cup arthroplasty, endoprosthesis, femoral osteotomy, or girdlestone resection.

    Reason

    Inner spherical radius of the shell is undersized.

    Code Info

    Batch No. 13EM03053

    Distribution

    Worldwide Distribution: US Distribution to NJ and FL; and the countries of: Colombia and Costa Rica.

    Quantity

    10 units