Recall Z-0040-2020— AZIYO BIOLOGICS
Class II · Terminated
Class II FDA medical device recall by AZIYO BIOLOGICS, initiated 2019-08-21, terminated 2020-09-17. It names 3 FDA 510(k) clearances: K182255, K173242, K140306. 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 brain stimulators and sacral nerve stimulators.. 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
3 on FDA's record- K182255 — CanGaroo Neuro Envelope (4 models)
- K173242 — CanGaroo Envelope (small), CanGaroo Envelope (medium), CanGaroo Envelope (large), CanGaroo Envelope (extra large)
- K140306 — CORMATRIX PROTECT ECM ENVELOPE
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
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 brain stimulators and sacral nerve stimulators.
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.