BEUDAMED
    FDA Recall Terminated

    Otto Bock Kimba Plus Pediatric Tilt-in-Space Postural Mobility Systems (Strollers), Product Numbers HR32571001-012, HRK3269=06-027_X, R32651001-012, HRK3283=01-026_X, HRK3269=01-026_X, HRK3283=02-026_X, HRK3269=02-026_X, HRK3283=03-027_X, HRK3269=03-027_X, HRK3283=04-027_X, HRK3269=04-027_X, HRK3283=05-026_X, HRK3269=05-026_X, and HRK3283=06-027_X

    Recall: Z-0181-04 · Initiated October 29, 2003

    Recall

    Recall Number
    Z-0181-04
    Event Number
    27588
    Firm
    Bock, Otto, Orthopedic Ind, Inc
    FEI Number
    2182293
    Product Code
    IOR
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 29, 2003
    Posted
    July 20, 2004
    Terminated
    November 7, 2005
    Address
    3000 Xenium Ln N, Minneapolis, MN, 55441-2661

    Description

    Otto Bock Kimba Plus Pediatric Tilt-in-Space Postural Mobility Systems (Strollers), Product Numbers HR32571001-012, HRK3269=06-027_X, R32651001-012, HRK3283=01-026_X, HRK3269=01-026_X, HRK3283=02-026_X, HRK3269=02-026_X, HRK3283=03-027_X, HRK3269=03-027_X, HRK3283=04-027_X, HRK3269=04-027_X, HRK3283=05-026_X, HRK3269=05-026_X, and HRK3283=06-027_X

    Reason

    Under certain conditions the tilt mechanism of the strollers may not function properly allowing the child to fall out if the seat belt is not fastened.

    Action

    Recall letters dated October 23, 2003 were sent to the consignees on 10/29/03 and 10/30/03. The letters requested that the consignees contact the firm''s Customer Service Department to report the affected units they have. The letter states that the Customer Service Department will send the consignees the necessary field modification kits and instructions to correct the problem in the units they have and have located at their customers.

    Distribution

    The product was distributed nationwide in the United States and to Canada and Mexico.