Recall Z-0039-2020— AZIYO BIOLOGICS

Name: FDA recall Z-0039-2020
Creator: U.S. Food and Drug Administration
Published: 2019-08-21

Class II · Terminated

Class II FDA medical device recall by AZIYO BIOLOGICS, initiated 2019-08-21, terminated 2020-09-17. It names one FDA 510(k) clearance: K140306. 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.. Reason: Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device..

Recalling firm: AZIYO BIOLOGICS
Classification: Class II
Status: Terminated
Initiated: 2019-08-21
Terminated: 2020-09-17
Firm location: Roswell, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K140306 — CORMATRIX PROTECT ECM ENVELOPECormatrix Cardiovascular, Inc.·cleared 2014-08-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.