BEUDAMED
    FDA Recall Terminated

    MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020

    Recall: Z-1221-04 · Initiated June 29, 2004

    Recall

    Recall Number
    Z-1221-04
    Event Number
    29495
    Firm
    Integra LifeSciences Corporation
    FEI Number
    3004608878
    Product Code
    HBL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 29, 2004
    Posted
    July 27, 2004
    Terminated
    November 24, 2004
    Address
    4900 Charlemar Drive, Cincinnati, OH, 45227

    Description

    MAYFIELD Radiolucent Disposable Adult Skull Pins (Sterile), Model 4-0-A-2020

    Reason

    Skull pins, which fractured below device specifications during QC testing, were distributed.

    Action

    The firm notified their customers of the recall via facsimile on 6/29/2004. The faxed notification was followed by a hard copy of the recall letter sent via overnight mail. The letter instructs the customers to immediate cease using of the affected product; complete the Fax Back form provided with the recall notice; and return the affected product to Integra for replacement.

    Distribution

    The product was distributed to the following states: NY, TX, MD, CO

    Quantity

    69 skull pins were distributed.