BEUDAMED
    FDA Recall Terminated

    PRO5100, PowerPro Battery Modular Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm, PRO5200, PowerPro Battery Two Trigger Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm, PRO5250, PowerPro Battery Two Trigger Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm, PRO5300 PowerPro Battery Oscillator Handpiece. PRO 5300 Oscillator Speed Range: 0-11,000 cpm, and PRO5400 PowerPro Battery Reciprocator Handpiece. Speed Range: 0-14,500 cpm+/- 500 cpm. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.

    Recall: Z-1950-2009 · Initiated July 31, 2009

    Recall

    Recall Number
    Z-1950-2009
    Event Number
    52803
    Firm
    Linvatec Corp. dba ConMed Linvatec
    FEI Number
    1017294
    Product Code
    HRX
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 31, 2009
    Posted
    October 1, 2009
    Terminated
    December 19, 2011
    Address
    11311 Concept Blvd, Largo, FL, 33773-4908

    Description

    PRO5100, PowerPro Battery Modular Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm, PRO5200, PowerPro Battery Two Trigger Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm, PRO5250, PowerPro Battery Two Trigger Handpiece. Drill mode Nominal Speed Range: 0-1250 rpm, PRO5300 PowerPro Battery Oscillator Handpiece. PRO 5300 Oscillator Speed Range: 0-11,000 cpm, and PRO5400 PowerPro Battery Reciprocator Handpiece. Speed Range: 0-14,500 cpm+/- 500 cpm. CONMED LINVATEC, 11311 CONCEPT BLVD, LARGO, FL 33773-4908 USA.

    Reason

    There is a potential the devices may self activate for their PowerPro, PowerProMax, and MPower I Handpieces manufactured prior to June 1, 2008.

    Action

    Consignees were notified via letter by FedEx delivery or equivalent method. If the product has been further distributed the consignee is requested to notify their consignees. The letter indicated the following risk mitigation actions until affected handpieces are returned to the manufacturer for preventive maintenance: 1) Apply supplied label to the identified handpieces by specific serial number, 2) If self-activation is experienced, discontinue use immediately and return to ConMed Linvtec and 3) Advise/remind the consignee to follow the manufacturers preventive maintenance intervals specified in the instructions for use manuals. Direct questions to ConMed Linvatec at 1-800-237-0169. Recall Expansion: New amended customer and distributor letters will be sent to those identified customer/distributor accounts. The letter will address the additional units.

    Distribution

    Worldwide Distribution including United States.

    Quantity

    4,772