BEUDAMED
    FDA Recall Terminated

    Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.

    Recall: Z-1465-2013 · Initiated April 26, 2013

    Recall

    Recall Number
    Z-1465-2013
    Event Number
    65209
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    April 26, 2013
    Posted
    June 5, 2013
    Terminated
    August 29, 2013
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Active Articulation E1. Intended for use with either primary or revision hip arthroplasty.

    Reason

    Biomet is recalling Active Articulation E1 Hip Bearing implants. Biomet has initiated this action following an investigation which identified that outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size. The implant itself is etched with the correct O.D. size.

    Action

    Biomet sent an Urgent Medical Device Recall letter dated April 26, 2013 to consignees detailing that the outer label indicates two conflicting O.D. sizes while the inner labels indicate an incorrect O.D. size. This action requires the immediate location and discontinued use of the product and its return to Biomet. Ciustomers were advised to: Immediately locate and remove the identified device(s) listed from circulation . -Carefully follow the instructions on the enclosed "FAX Back Response Form" . - Fax a copy of the Response Form to 574-372-1683 prior to return of product. -Use priority carrier for your shipment. - If you have further distributed this product, you MUST notify hospital personnel of this action via the enclosed "Dear O.R. Manager" notice. This letter MUST be given to hospital personnel responsible for receiving recall notices. However, you are charged with the location and return of these products.

    Distribution

    Distributed in New York.

    Quantity

    8 units