BEUDAMED
    FDA Recall Terminated

    PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage.

    Recall: Z-0552-2021 · Initiated November 10, 2020

    Recall

    Recall Number
    Z-0552-2021
    Event Number
    86807
    Firm
    TissueTech, Inc.
    FEI Number
    3009809074
    Product Code
    NQB
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    November 10, 2020
    Terminated
    July 6, 2023
    Address
    8305 NW 27th St, Ste 101, Doral, FL, 33122-1934

    Description

    PROKERA Slim, non-sterile - Product Usage: Biologic corneal bandage.

    Reason

    Potential exposure of product to microbial contamination.

    Action

    Written notification letter titled, "URGENT Medical Device Voluntary Recall Notification PROKERA Self-Retaining Biologic Corneal Bandage" was sent to all consignees on 11/10/2020. Each customer was sent a letter as well as a reconciliation sheet that listed the specific impacted serial IDs from the PROKERA product line (including PROKERA, PROKERA PLUS and PROKERA Slim). The required action's mentioned in the letter include: Notifying the firm via email at [email protected] whether the impacted product remains at the consignee's facility using the reconciliation sheet attached to the letter. The letter also mentions for the consignee to discontinue using any remaining units within the impacted lots. Bio-Tissue will provide the consignee with shipping materials to return affected product.

    Distribution

    US Nationwide distribution including in the states of FL, MN, NY, NC, SC, NJ, GA, PA, MD, DC, OH, WA, MI, CO, KS, TN, ME, AL, AR, TX, KY, MA, CA, CT, and OK.

    Quantity

    75 units