The Recall Desk

FDA (Devices) recall action 83652

AZIYO BIOLOGICS recalled 2 products on 2019-10-16

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2019-10-16
Critical
0
Units
3,711

Why these products were recalled

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

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2019-10-16

    Aziyo BioEnvelope Surgical Mesh Recalled for Possible Suture Brittleness

    Aziyo Biologics is recalling BioEnvelope surgical mesh envelopes due to possible suture brittleness or breakage along the seam before the expiration date.

    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 (Larg
    Category
    Distribution
    30 states
  • HighFDA (Devices)··2019-10-16

    AZIYO BIOLOGICS Recalls CanGaroo Envelopes Due to Suture Brittleness

    AZIYO BIOLOGICS is recalling CanGaroo Envelopes because sutures may become brittle or break before expiration. The devices are used to secure cardiac and neurostimulator implants.

    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 Env
    Category
    Distribution
    30 states