# FDA recall Z-0039-2020

> **AZIYO BIOLOGICS** · Class II · device recall initiated 2019-08-21.

## 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 for recall

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

## 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.

## Key facts

- **Recall number:** Z-0039-2020
- **Recalling firm:** AZIYO BIOLOGICS
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-08-21
- **Report date:** 2019-10-16
- **Termination date:** 2020-09-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Roswell, GA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0039-2020

## Citation

> AI Analytics. FDA recall Z-0039-2020. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-0039-2020. Source: US FDA. Licensed CC0.

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