BEUDAMED
    FDA Recall 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 · Initiated January 31, 2014

    Recall

    Recall Number
    Z-1266-2014
    Event Number
    67576
    Firm
    Bock, Otto, Orthopedic Ind, Inc Two Carlson
    FEI Number
    2182293
    Product Code
    IMP
    Status
    Terminated
    Root Cause
    Unknown/Undetermined by firm
    Initiated
    January 31, 2014
    Posted
    March 21, 2014
    Terminated
    May 7, 2018
    Address
    Parkway North, Suite 100, Minneapolis, MN, 55447

    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.

    Action

    An Urgent Voluntary Device Recall letter was sent to customers beginning 1/31/2014. The letter identified the affected material numbers, described the reason for recall, and asked that product be returned or destroyed. A response Questionnaire was asked to be completed and returned.

    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)