BEUDAMED
    FDA Recall Terminated

    TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.

    Recall: Z-1273-2020 · Initiated December 30, 2019

    Recall

    Recall Number
    Z-1273-2020
    Event Number
    84748
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1219602
    Product Code
    MBI
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    December 30, 2019
    Terminated
    May 11, 2021
    Address
    130 & 120 Forbes Blvd, Mansfield, MA, 02048

    Description

    TwinFix Ti 2.8 mm HS Suture Anchor - Product Usage: A fixation device intended to provide secure attachment of soft tissue to bone.

    Reason

    Due to a potential for sterile barrier breach. A complaint was received that indicated the protective tube of the device came off inside the pouch enabling the pointed end of the device to puncture the package causing a breach of the sterile barrier, which could affect the sterility of the device.

    Action

    Smith Nephew "Urgent Medical Device Recall Notice R-2019-22" letter dated December 30, 2019. Customers were advised to: 1.Please inspect your inventory and locate any devices from the listed product and batch numbers on the first page of this Field Action Notification, and quarantine them immediately. a. If you are a distributor, you must notify your customers of the field action and ensure that these actions are carried out. 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] or fax to 901-566-7975. 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 states of AZ, ID, MO, NC, ND, NE, OK, SC, TN, and countries of AE, AU, CA, CH, ES, FI, JP, PR, SG.

    Quantity

    82 distributed throughout US:AZ, ID, MO, NC, ND, NE, OK, SC, TN. 243 distributed OUS: AE, AU, CA, CH, ES, FI, JP, PR, SG. Total: 325 units