BEUDAMED
    FDA Recall Terminated

    50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.

    Recall: Z-1039-2016 · Initiated February 4, 2016

    Recall

    Recall Number
    Z-1039-2016
    Event Number
    73172
    Firm
    Stryker Instruments Div. of Stryker Corporation
    FEI Number
    1811755
    Product Code
    GDF
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    February 4, 2016
    Posted
    March 3, 2016
    Terminated
    May 9, 2017
    Address
    4100 E Milham Ave, Portage, MI, 49002-9704

    Description

    50000 (Inrad) AccuPlace Drace Stereotaxic Needle Guide; Assists the user with inserting a needle at a predetermined angle for computer tomography.

    Reason

    During an evaluation of the product packaging, it was determined that there is a potential for the product to cause damage to the packaging, creating a possible breach in sterility.

    Action

    Stryker sent URGENT MEDICAL DEVICE RECALL NOTIFICATIONS to Customers via Overnight service. Stryker Sales Representatives were notified via email. 1. Immediately review this Recall Notification. 2. Check all stock areas and/or operating room storage to determine how many AccuPlace" Needle Guides are at your facility. Discontinue use of the AccuPlace" Needle Guides. 3. Complete the enclosed Business Reply Form (BRF) to confirm receipt of this notification and identify how many, if any, affected items are currently in your inventory. Please complete and return the BRF even if you dont have any affected product on hand. Note: Your signature on the BRF indicates that you received and understand this Notification and have followed the instructions in the Notification. 4. If you have further distributed this product, please forward this letter and the attached Business Reply Form (BRF) to all affected locations. Please indicate each location on the BRF. 5. Fax the completed BRF to Stryker Instruments Regulatory Department at 866-521-2762, or scan and email a copy to [email protected]. 6. If the BRF for your facility indicates that recalled product is currently on hand, a FedEx label will be emailed to you. This shipping label should be used to return recalled product. Upon receipt of the recalled product, a credit will be issued to your account. In addition, Stryker Instruments sent recall notifications directly to facilities that received recalled product(s) originally shipped by Inrad. Facilities that received products from both Stryker and Inrad will receive one recall notification. The Business Reply Form will be pre-filled to indicate specifically what recalled products were sent to each facility, including the quantity and Product Number(s).

    Distribution

    Nationwide Distribution-including the states of AZ, CA, CO, CT, FL, GA, IA, KS, MA, MI, MN, MO, NY, OH, OK, PA, TX, VA, WA, and WI.

    Quantity

    5,800 units total