BEUDAMED
    FDA Enforcement Class II Terminated

    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

    Recall: Z-1391-2013 · Reported June 5, 2013

    Enforcement

    Recall Number
    Z-1391-2013
    Event ID
    63204
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Orthovita, Inc., dBA Stryker Orthobiologics.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 5, 2013
    Initiation Date
    November 10, 2012
    Classification Date
    May 24, 2013
    Termination Date
    October 29, 2014
    Address
    45 Great Valley Pkwy, N/A, Malvern, PA, 19355-1302, United States

    Description

    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Beveled Needle, 4", Part Number 2110-0505 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

    Reason

    There have been a few reported cases of the catheter breaking when removing the Aliquot catheter from the needle during vertebroplasty procedures. This has been attributed to bending of the catheter during the retraction from the needle. It was determined to be use errors. The correction is limited to a revision of the Directions for Use.

    Code Info

    Manufacturer Part Number 2110-0505, Lot Numbers E909002 and E909002R

    Distribution

    USA Nationwide Distribution in the states of AZ, CA, CO, CT, DE, FL, GA, HI, IL, IN, KS, KY, LA, MD, ME, MI, MO, NC, ND, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, and WI.

    Quantity

    35