BEUDAMED
    FDA Recall Terminated

    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 Product Usage: Facilitate placement of bone cement in weakened or diminished bone

    Recall: Z-1395-2013 · Initiated November 10, 2012

    Recall

    Recall Number
    Z-1395-2013
    Event Number
    63204
    Firm
    Orthovita, Inc., dBA Stryker Orthobiologics.
    FEI Number
    1000307073
    Product Code
    OAR
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    November 10, 2012
    Posted
    May 24, 2013
    Terminated
    October 29, 2014
    Address
    45 Great Valley Pkwy, Malvern, PA, 19355-1302

    Description

    Stryker Orthobiologics Aliquot Delivery System Manual Surgical Instrument - Aliquot Reamer, 8", Part Number 2110-0525 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.

    Action

    Stryker sent an Urgent Medical Device Correction letter dated November 10, 2012 to all affected customers. The letter identified the affected product, problem issue, potential hazards and actions to be taken. Customers were instructed to immediately review this notification and the attached IFU. Customers were asked to complete and sign the enclosed Business Reply Form and fax a copy to 1-484-323-8803. For questions contact Stryker Orthobiologics.

    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

    5