BEUDAMED
    FDA Recall Terminated

    Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge Stryker handpiece battery packs only. The battery charger has the optional functionality to track device usage data. Usage data is accumulated by Stryker and reports are able to be provided to the customer. For powered surgical instruments.

    Recall: Z-1587-2015 · Initiated March 25, 2015

    Recall

    Recall Number
    Z-1587-2015
    Event Number
    70933
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    HWE
    Status
    Terminated
    Root Cause
    Software design
    Initiated
    March 25, 2015
    Posted
    May 7, 2015
    Terminated
    July 8, 2015
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704

    Description

    Universal Charger Product Usage: The Stryker Universal Battery Charger is designed to be used in conjunction with and provide power to non-sterile and sterile batteries. The Stryker Universal Battery Charger is a four station, modular battery charger intended to charge Stryker handpiece battery packs only. The battery charger has the optional functionality to track device usage data. Usage data is accumulated by Stryker and reports are able to be provided to the customer. For powered surgical instruments.

    Reason

    The Stryker Universal Battery Charger is not transmitting usage data to the Stryker Cloud as designed. The firm is initiating a software correction to address the issue.

    Action

    Stryker issued e-mail notices to distributors and reps on March 26, 2015 advising that all battery charges would receive a software update to provide a field correction for the upgrade to units to be able to track device usage data to Stryker as designed. There is no customer action required, the chargers will transmit a message to Stryker once the upgrade is complete. Please contact Kelly Jo Davis at 269-389-2921 with any questions.

    Distribution

    US Nationwide in the states of AL, AR, AZ, CA, CO, FL, GA, IA, IL, IN, KS, KY, MD, MI, MO, MS, MT, NC, NH, NV, NY, OH, OK, PA, SC, TN, TX, UT, VA, VT, WA, WI and the foreign country of: Canada

    Quantity

    223 chargers