BEUDAMED
    FDA Enforcement Class II Terminated

    BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.

    Recall: Z-0039-2020 · Reported October 16, 2019

    Enforcement

    Recall Number
    Z-0039-2020
    Event ID
    83652
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    AZIYO BIOLOGICS
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 16, 2019
    Initiation Date
    August 21, 2019
    Classification Date
    October 4, 2019
    Termination Date
    September 17, 2020
    Address
    1100 Old Ellis Rd, N/A, Roswell, GA, 30076-4992, United States

    Description

    BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope (Extra Large) (single pack); 4. BioEnvelope (Extra Extra Large) (single pack); 5. BioEnvelope (Large) (5-pack); 6. BioEnvelope (Medium) (5-pack); 7. BioEnvelope (Extra Extra Large) (5-pack); 8. BioEnvelope (Extra Large) (5-pack) Product Usage: The BioEnvelope is intended to securely hold a cardiac implantable electronic device to create a stable environment when implanted in the body. The cardiac implantable electronic devices that may be used with the CanGaroo Envelope include pacemaker pulse generators, defibrillators, or other cardiac implantable electronic devices.

    Reason

    Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.

    Code Info

    1. Catalog Number 440576 (UDI Number 004035479160524) Lot Numbers: M18A1010, M18A1022, M18C1070, M18G1185; 2. Catalog Number 440577 (UDI Number 004035479160531) Lot Number M18A1021; 3. Catalog Number 440578 (UDI Number 004035479160548) Lot Numbers: M18A1008, M18B1051, M18G1181; 4. Catalog Number 440579 (UDI Number 004035479160555) Lot Numbers: M18F1146, M18G1188; 5. Catalog Number 440622 (UDI Number 004035479160616) Lot Numbers: M18A1007, M18D1080; 6. Catalog Number 440623 (UDI Number 004035479160623) Lot Numbers: M18A1015, M18C1071; 7. Catalog Number 440625 (UDI Number 004035479160647) Lot Number M18G1189; 8. Catalog Number 440626 (UDI Number 004035479160654) Lot Numbers: M18A1014; M18B1054

    Distribution

    US Nationwide distribution including the states of AL, AR, AZ, CA, FL, GA, HI, IL, IN, KS, KY, LA, LA, MI, MN, MO, MS, NC, NM, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, WA, WI.

    Quantity

    1018 units