Z-0039-2020Class II

BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2...

Name: Z-0039-2020 BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2...
Creator: Aziyo Biologics
Published: 2019-08-21
License: https://open.fda.gov/license/

Boston Scientific Corporation / initiated 2019-08-21 / Terminated

FDA source

AZIYO BIOLOGICS began a recall of BioEnvelope, surgical mesh envelope. Labeled as the following: 1. BioEnvelope (Medium) (single pack); 2. BioEnvelope (Large) (single pack); 3. BioEnvelope... on 2019-08-21. FDA classified it as Class II and gives the reason as "Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0039-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-21
Posted: 2019-10-04
Terminated: 2020-09-17
Recalling firm: Boston Scientific Corporation
Product: 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 code: FTM Mesh, Surgical
Reason for recall: Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
FDA root cause: Under Investigation by firm
Action: 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 ([email protected]), 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.
Quantity in commerce: 1018 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0039-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0039-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-04
Z-0040-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-16	2019-10-04

Product code FTM

K140306Class IICormatrix Protect Ecm EnvelopeCormatrix Cardiovascular, Inc. / cleared 2014-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)