BEUDAMED
    FDA Recall Open, Classified

    Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Small Obturator Trocar (Model Number 330.013) 2. DKs Small Lighted Cannula (Model Number 330.014) 3. DKS Small Kerrison (330.016)

    Recall: Z-0651-2025 · Initiated October 30, 2023

    Recall

    Recall Number
    Z-0651-2025
    Event Number
    95476
    Firm
    Folsom Metal Products, Inc.
    FEI Number
    3006803588
    Product Code
    HAE
    Status
    Open, Classified
    Root Cause
    No Marketing Application
    Initiated
    October 30, 2023
    Posted
    December 6, 2024
    Address
    1449 Court Pl, Pelham, AL, 35124-1858

    Description

    Small DKS Disposable Kerrison System, Catalog Number DKS-63030, instrument sets that come in two sizes (3.75mm and 6.35mm) containing: 1. DKS Small Obturator Trocar (Model Number 330.013) 2. DKs Small Lighted Cannula (Model Number 330.014) 3. DKS Small Kerrison (330.016)

    Reason

    Units were not intended for commercial distribution and inadvertently distributed.

    Action

    Folsom Metal Products, Inc. d/b/a Frontier Devices, initially notified consignees via telephone during November 2023. An "URGENT: MEDICAL DEVICE RECALL" letter dated 11/8/2024 was sent to consignees on about 11/08/2024. Consignees were instructed to complete and return the Medical Device Recall Response Acknowledgement and Receipt form to document receipt of and understanding of the recall, as well as reconciliation of affected units. Immediately examine your inventory and quarantine any product remaining in your possession that is subject to this recall. If you are in possession of product that is subject to this recall, please return the product by mail to: Frontier Devices at 1449 Court Place, Pelham, AL 35124; Fax to: (205)733-8445 or email: [email protected]. If you no longer have product in your inventory, but destroyed the recalled product, please complete the enclosed Certificate of Destruction Form in addition to the Medical Device Recall Return Response Acknowledgment and Receipt form. If you have any questions, please contact Jennifer Martin at (205) 733-0901 or by email at [email protected] We are available from 9AM to 5PM CST, Monday through Friday.

    Distribution

    US distribution to KS, LA, MI, NY, TX.

    Quantity

    6 sets