BEUDAMED
    FDA Enforcement Class II Ongoing

    CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO

    Recall: Z-2405-2023 · Reported August 23, 2023

    Enforcement

    Recall Number
    Z-2405-2023
    Event ID
    92764
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Conformis, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    August 23, 2023
    Initiation Date
    June 16, 2023
    Classification Date
    August 16, 2023
    Address
    600 Technology Park Dr # 400, Billerica, MA, 01821-4154, United States

    Description

    CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO

    Reason

    30mm screws were labeled as 25mm screws.

    Code Info

    Model No. HAA-030-0625-000101; UDI-DI: M572HAA0300625011; Lot No. 1232071.

    Distribution

    US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, & VA.

    Quantity

    25 units