# FDA recall Z-0040-2020

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

## 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 brai

## 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-0040-2020
- **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-0040-2020

## Citation

> AI Analytics. FDA recall Z-0040-2020. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0040-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*