BEUDAMED
    FDA Recall Terminated

    HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE

    Recall: Z-0678-2019 · Initiated November 15, 2018

    Recall

    Recall Number
    Z-0678-2019
    Event Number
    81641
    Firm
    Howmedica Osteonics Corp.
    FEI Number
    3004024955
    Product Code
    MQV
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    November 15, 2018
    Terminated
    June 18, 2020
    Address
    2 Pearl Ct, Allendale, NJ, 07401-1611

    Description

    HydroSet XT Injectable HA Bone Cement, REF 897005, STERILE

    Reason

    Incorrect expiry date of 9-Feb-20 Correct expiry date is 30-Aug-19

    Action

    On November 15, 2018, Stryker issued Urgent Medical Device Recall notices to customers via Fedex. Customers were advised to take the following actions: 1. Inform users of the medical device recall and forward a copy of the notice to all those individuals who need to be aware within the organization. 2. Examine inventory to identify impacted HydroSet kits. 3. Immediately quarantine any affected product. 4. Complete and return the Business Reply Form via email to [email protected] or via fax to 1-888-345-3845. 5. Return all affected product available at your location to the following address: Stryker Orthopaedics/PFA Product Returns Attn: Distribution Inventory Team 325 Corporate Drive, Dock M-East, Mahwah, NJ 07431, Ref. PFA 1878253

    Distribution

    CO, FL, GA, IA, MA, ME, MI, MN, NC, ND, NH, NY, PA, SC, TN, TX, VA, WI & WV