BEUDAMED
    FDA Recall Terminated

    Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, ID28mm, OD48mm Bipolar Cap, ID28mm, OD50mm Bipolar Cap, ID28mm, OD52mm Bipolar Cap, ID28mm, OD54mm Bipolar Cap, ID28mm, OD56mm

    Recall: Z-1383-2013 · Initiated February 20, 2013

    Recall

    Recall Number
    Z-1383-2013
    Event Number
    64588
    Firm
    Orthopedic Alliance LLC
    FEI Number
    3004022256
    Product Code
    KWY
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    February 20, 2013
    Posted
    May 24, 2013
    Terminated
    March 26, 2014
    Address
    26157 Jefferson Ave, Murrieta, CA, 92562-9561

    Description

    Bipolar Cap, ID26mm, OD42mm Bipolar Cap, ID28mm, OD44mm Bipolar Cap, ID28mm, OD46mm Bipolar Cap, ID28mm, OD48mm Bipolar Cap, ID28mm, OD50mm Bipolar Cap, ID28mm, OD52mm Bipolar Cap, ID28mm, OD54mm Bipolar Cap, ID28mm, OD56mm

    Reason

    The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Orthopedic Alliance because the directions for use and surgical techniques were not being provided to every physician and for every surgery.

    Action

    A recall letter dated 3/8/13 was sent to all customers who purchased loaner bins and sterilization trays for implants and instruments from Orthopedic Alliance. The letter informed the customers of the problem identified and the actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.

    Distribution

    Nationwide Distribution including the states of CA, MD, TX, NV, and WI.

    Quantity

    37 units