BEUDAMED
    FDA Recall Open, Classified

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

    Recall: Z-2405-2023 · Initiated June 16, 2023

    Recall

    Recall Number
    Z-2405-2023
    Event Number
    92764
    Firm
    Conformis, Inc.
    FEI Number
    3009844603
    Product Code
    OQG
    Status
    Open, Classified
    Root Cause
    Error in labeling
    Initiated
    June 16, 2023
    Posted
    August 16, 2023
    Address
    600 Technology Park Dr, # 400, Billerica, MA, 01821-4154

    Description

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

    Reason

    30mm screws were labeled as 25mm screws.

    Action

    The firm initially notified the surgeon who possessed affected devices of this recall event via telephone and subsequently by email on 7/12/2023. The surgeon mailed back all affected product to Conformis to be quarantined. Sales representatives were informed of this recall event and sent all affected devices in their possession back to Conformis to be quarantined.

    Distribution

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

    Quantity

    25 units