Recall Z-0040-2020
Aziyo Biologics · initiated August 21, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
Reason for recall
Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
FDA-determined cause: Under Investigation by firm
Action taken
Aziyo Biologics notified customers on about 08/26/2019 via letter. The letter informed customers of potential suture brittleness or breakage along the envelope seam prior to the expiration of the device. Customers were instructed to immediately discontinue use of affected lots and return them to Aziyo for replacement at no cost. Customers are directed to contact Customer Service at 877-651-2628 to initiate the return, using RGA # 19-1994R. Additionally, customers are instructed to acknowledge of receipt of the recall notice by email (customerservice@aziyo.com), fax (678-680-5486), or telephone (877-651-2628), and return of the Acknowledgement and Receipt Form attached to the recall notification. An updated consignee letter was sent on about 09/04/2019. The letter contained the same information and instructions but notified customers that this action was a removal and not a market withdrawal.
Details
- Recall number
- Z-0040-2020
- Initiated
- August 21, 2019
- Terminated
- September 17, 2020
- Product code
- FTM – Mesh, Surgical
- Quantity
- 2693 units
- 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.
- Recalling firm
- Aziyo Biologics, Roswell, GA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0039-2020 Class II | BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium)…Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device. | 08/21/2019Terminated |