BEUDAMED
    FDA Recall Terminated

    Celsus prosthetic foot, Product Number 103658-00. The Celsus is intended for low impact level lower limb prosthesis users weighing up to 300 lbs.

    Recall: Z-1650-2012 · Initiated April 5, 2012

    Recall

    Recall Number
    Z-1650-2012
    Event Number
    61701
    Firm
    College Park Industries, Inc.
    FEI Number
    1000220701
    Product Code
    ISH
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    April 5, 2012
    Posted
    May 23, 2012
    Terminated
    July 31, 2012
    Address
    17505 Helro, Fraser, MI, 48026-2226

    Description

    Celsus prosthetic foot, Product Number 103658-00. The Celsus is intended for low impact level lower limb prosthesis users weighing up to 300 lbs.

    Reason

    An incorrect shorter part ( pyramid) was installed in the foot. A foot of this size and configuration requires a longer pyramid. Customers requiring the extra firm configuration may have a minimal risk of component failure, which could be implicated in a potential fall.

    Action

    All customers who received affected product were initially contacted via phone on April 5, 2012 and made aware of the recall, including instructions to notify customers immediately and arrange replacements. A "Recall Notice" letter dated April 24, 2012 was sent to customers describing the problem and the recommended actions. Contact reference person is Kimberly Light, 1 800-728-7950, [email protected].

    Distribution

    Worldwide Distribution - USA, including the states of CA, MA, ME, WA, TX, VA, AZ and the country of England.

    Quantity

    11