FDA Device recall Z-0040-2020
CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack)
- FDA Device
- Class II
- terminated
- Published 2019-10-16
On 2019-10-16 the FDA classified a Class II recall of CanGaroo Envelopes labeled as the following: 1. CanGaroo Envelope (Large) (single pack) by Aziyo Biologics, citing possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0040-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-08-21 |
| Published | 2019-10-16 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Aziyo Biologics |
| Distribution | US |
Product
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.
Identifiers
| code_info | 1. Catalog Number CMCV-009-LRG (UDI Number 000859389005065) Lot Numbers: M18B1053, M18D1080, M18D1081, M18D1091, M18D1…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0040-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.