BEUDAMED
    FDA Enforcement Class II Terminated

    CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator 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. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

    Recall: Z-0040-2020 · Reported October 16, 2019

    Enforcement

    Recall Number
    Z-0040-2020
    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

    CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack); 2. CanGaroo Envelope (Medium) (single pack); 3. CanGaroo Envelope (Extra Large) (single pack); 4. CanGaroo Envelope (Extra Extra Large) (single pack); 5. CanGaroo Envelope (Large) (5 pack); 6. CanGaroo Envelope (Medium) (5 pack); 7. CanGaroo Envelope (Extra Large) (5 pack); 8. CanGaroo Envelope (Extra Extra Large) (5 pack) Product Usage: The CanGaroo Envelope is intended to securely hold a cardiac implantable electronic device or an implantable neurostimulator 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. The implantable neurostimulator devices that may be used with the CanGaroo Envelope include vagus nerve stimulators, spinal cord neuromodulators, deep brain stimulators and sacral nerve stimulators.

    Reason

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

    Code Info

    1. Catalog Number CMCV-009-LRG (UDI Number 000859389005065) Lot Numbers: M18B1053, M18D1080, M18D1081, M18D1091, M18D1095, M19B1077, M19C1083, M19D1144, M19D1148; 2. Catalog Number CMCV-009-MED (UDI Number 000859389005034) Lot Numbers: M18C1071, M18D1088; 3. Catalog Number CMCV-009-XLG (UDI Number 000859389005072) Lot Numbers: M18B1051, M18B1052, M18B1054, M18C1068, M18C1069, M19D1160, M19D1163; 4. Catalog Number CMCV-009-XXL (UDI Number 000859389005119) Lot Numbers: M18D1094, M19C1101, M19C1123; 5. Catalog Number CMCV-010-LRG (UDI Number 010859389005062) Lot Numbers: M18A1007, M18M1303, M18N1330, M19B1071, M19C1104, M19C1119; 6. Catalog Number CMCV-010-MED (UDI Number 010859389005031) Lot Number M18A1015; 7. Catalog Number CMCV-010-XLG (UDI Number 010859389005079) Lot Numbers: M18F1160, M18F1161; 8. Catalog Number CMCV-010-XXL (UDI Number 010859389005116) Lot Number M18F1159

    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

    2693 units