BEUDAMED
    FDA Enforcement Class II Terminated

    Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705, 476C00=SK706, 476C00=SK707, The following material numbers were not distributed within the US: 476C00=SK751, 476C00=SK752, 476C00=SK753, 476C00=SK754, 476C00=SK755, 476C00=SK756, 476C00= SK757.

    Recall: Z-1266-2014 · Reported March 26, 2014

    Enforcement

    Recall Number
    Z-1266-2014
    Event ID
    67576
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bock,Otto,Orthopedic Ind,Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 26, 2014
    Initiation Date
    January 31, 2014
    Classification Date
    March 20, 2014
    Termination Date
    May 7, 2018
    Address
    Two Carlson Parkway North, Suite 100, Minneapolis, MN, 55447, United States

    Description

    Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705, 476C00=SK706, 476C00=SK707, The following material numbers were not distributed within the US: 476C00=SK751, 476C00=SK752, 476C00=SK753, 476C00=SK754, 476C00=SK755, 476C00=SK756, 476C00= SK757.

    Reason

    Otto Bock is recalling all Aerial and Aerial Active Wheelchair Cushions from specific material numbers. During internal testing, it was discovered that there is a small risk of flammability to the cushion after it has been washed at high temperatures. The cushions should either be returned to Otto Bock or destroyed.

    Code Info

    all cushions with the following material numbers: SK757 476C00=SK701, 476C00=SK702, 476C00=SK703, 476C00=SK704, 476C00=SK705, 476C00=SK706, 476C00=SK707, The following material numbers were not distributed within the US: 476C00=SK751, 476C00=SK752, 476C00=SK753, 476C00=SK754, 476C00=SK755, 476C00=SK756, 476C00= SK757.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Australia, Austria, Bosnia and Herzegovina, Brazil, China, Columbia, Croatia, Denmark, France, Germany, Greece, Hong Kong, Hungary, Iceland, Japan, Mexico, Netherlands, Poland, Romania, Russia, South Africa, Spain, Sweden, Switzerland, Thailand, and United Kingdom.

    Quantity

    464 units (US 113, OUS 351)