BEUDAMED
    FDA Recall Open, Classified

    Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head in surgical procedures.

    Recall: Z-0177-2023 · Initiated September 20, 2022

    Recall

    Recall Number
    Z-0177-2023
    Event Number
    90848
    Firm
    Baxter Healthcare Corporation
    FEI Number
    1417572
    Product Code
    GDC
    Status
    Open, Classified
    Root Cause
    Other
    Initiated
    September 20, 2022
    Posted
    November 3, 2022
    Address
    1 Baxter Pkwy, Deerfield, IL, 60015-4625

    Description

    Allen Standard Starburst, Mayfield/Doro, STANDARD SPINE POSITIONERS CMPT, REF A-70710, #800103. Component to position and support the patients head in surgical procedures.

    Reason

    the adhesive, applied to screws and bolts as an additional holding force, may not cure correctly, and as a result, could result in a loss of holding and reduced mechanical integrity.

    Action

    The firm issued an Urgent Medical Device Correction notice to their consignee on 09/20/2022 by email. The notice explained the problem, risk, and requested the following: "Actions to be taken by Customer: 1. Identify the impacted lot number listed on page 1 and stop any use of the product immediately. 2. Hillrom will contact you to perform a correction of your impacted device as soon as possible." The firm issued an Urgent Medical Device Recall notice to their consignees on 09/27/2022 by FedEx 2nd day delivery. The notice explained the problem, risk, and requested the following: "Actions to be taken by Customer: 1. Identify the impacted lot numbers listed in the above table and replace with the enclosed device that accompanies this notification. 2. Please return the impacted unit per RMA instructions attached within 10 business days. Actions to be taken by Distributor: 1. Please forward this notification to your end users along with replacement parts accompanying this notification. 2. Please request return of the impacted devices from your end users and return the devices to Hillrom, per RMA instructions attached." Both notices provided the following contact information: "Contact reference person If you have any questions regarding this Urgent Medical Device Correction, please contact Hillrom Technical Support at 800-445-3720 or [email protected]"

    Distribution

    MI, BA, WI, WA, TX, and Germany, Japan, South Korea, Sweden, South Africa

    Quantity

    2 units