AZIYO BIOLOGICS: Medical Device Recall in 2019 - (Recall #: Z-0039-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: August 21, 2019

Date Posted: October 16, 2019

Recall Number: Z-0039-2020

Event ID: 83652

Reason for Recall:

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

Status: Terminated

Product Quantity: 1018 units

Code Information:

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 Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated