BEUDAMED
    FDA Recall Terminated

    EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip.

    Recall: Z-1671-2015 · Initiated April 24, 2015

    Recall

    Recall Number
    Z-1671-2015
    Event Number
    71185
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    April 24, 2015
    Posted
    May 26, 2015
    Terminated
    October 15, 2015
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704

    Description

    EliteCore Full Core Biopsy Device. EliteCore 18G, 20cm with and without HiLiter tip, 15 cm with and without HiLiter tip, and 10 cm with and without HiLiter tip.

    Reason

    Potential for the device cannula to overthrow past the intended length.

    Action

    Stryker sent an Urgent Medical Device Recall Notification letter dated May 5, 2015, to all affected customers via Fed Ex overnight. Customers were instructed to qaurantine any product found, return the repsonse form even if there is no product on hand, forward the letter if further distribution of recalled product occurred, return recalled product to Stryker. Customers were instructed to 269-389-2458 with any questions.

    Distribution

    US Nationwide Distribution including AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MN, MO, MS, NJ, NM, NV, NY, OK, OR, PA, TN, TX, UT, VA, and WI.

    Quantity

    1,420 Units