BEUDAMED
    FDA Recall Terminated

    Fischer Cone Biopsy Excisor - Medium Model: 900-151

    Recall: Z-0615-06 · Initiated March 10, 2006

    Recall

    Recall Number
    Z-0615-06
    Event Number
    34810
    Firm
    Apple Medical Corporation
    FEI Number
    1216677
    Product Code
    HGI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 10, 2006
    Posted
    April 6, 2006
    Terminated
    March 7, 2016
    Address
    28 Lord Rd, Ste 135, Marlborough, MA, 01752-4549

    Description

    Fischer Cone Biopsy Excisor - Medium Model: 900-151

    Reason

    Change in product material may be cause for wire breaking, and tip burning and melting during procedure. Broken pieces of the device may need to be retrieved from patient.

    Action

    Apple Medical Corporation issued letters dated March 21, 2006 to direct accounts and distributors via US Mail. Distributors are requested to sub-recall. Product is to be returned to the firm and destroyed.

    Distribution

    Nationwide Foreign: Australia, Austria, Taiwan, England, FInland, Germany, Iceland, Israel, Italy, Portugal, Hong Kong, Spain, The Netherlands, Chile.

    Quantity

    2,813.0 boxes