BEUDAMED
    FDA Recall Terminated

    VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder implant fixation. VERSABOND AB includes the antibiotic- gentamycin.

    Recall: Z-0933-2021 · Initiated December 18, 2020

    Recall

    Recall Number
    Z-0933-2021
    Event Number
    87035
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    LOD
    Status
    Terminated
    Root Cause
    Storage
    Initiated
    December 18, 2020
    Terminated
    May 1, 2023
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    VERSABOND AB 40 GRAMS FORMULATION 2, antibiotic infused bone cement, Product Number: 71271440 - Product Usage: VERSABOND is a medium viscosity bone cement which can be used for hip, knee, and shoulder implant fixation. VERSABOND AB includes the antibiotic- gentamycin.

    Reason

    Potential heat and humidity exposure. The affected lot contained an atypical sandy, flaky or grainy consistency when mixing.

    Action

    A Recall notification letter titled, "Urgent Medical Device Recall Notice" was sent to consignees on 12/18/2020 via email and FedEx. The letter instructs the consignee to follow the instructions on the attached response form. The response form provides the following instructions: "1. Please inspect your inventory and locate any devices from the listed product and batch numbers enclosed with this Urgent Medical Device Recall Notice, and quarantine them immediately. a. If you are a sales rep or distributor, you must notify your customers of the field action and ensure that the required actions are complete. b. Include the customers account number and name in the table below. 2. If you have no product to return, please put an X in the appropriate location below. 3. If you have product to return, please list the item, batches and quantities that you are returning in the appropriate boxes below. 4. Complete the remainder of the form, sign and send to [email protected]. Please Note even if you have no product to return, this form must be completed, signed and returned. 5. Once the form is received by Smith & Nephew, you will be sent a Return Authorization (RA) number. If you have any questions or concerns regarding this recall please contact [email protected]."

    Distribution

    Worldwide distribution - US Nationwide distribution in the state of OH and the countries of Dubai, Canada, Korea, Chile, Puerto Rico, Panama, and Costa Rica.

    Quantity

    5190 devices