The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0039-2020·Announced 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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a potential structural defect (suture brittleness/breakage) that could compromise the stability of an implanted cardiac device. While no specific injuries or illnesses are reported in the source text, the risk of harm from a failing implantable device component warrants a High severity rating under the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Aziyo Biologics is recalling 1,018 units of BioEnvelope surgical mesh envelopes. The BioEnvelope is intended to securely hold a cardiac implantable electronic device, such as a pacemaker or defibrillator, to create a stable environment when implanted in the body. The recall covers various sizes and pack configurations, including single packs and 5-packs.

The recall is being issued because of possible suture brittleness or breakage along the Envelope seam before the expiration date of the device. The affected products were distributed nationwide in the United States, including in Alabama, Arkansas, Arizona, California, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.

Healthcare providers and patients should check their inventory or medical records for the specific catalog numbers and lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to Aziyo Biologics or the distributor. Patients who have already had the device implanted should contact their healthcare provider for guidance.

The recalled product

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…
Manufacturer
AZIYO BIOLOGICS
Category
Medical Device — Surgical Mesh
Hazard
Affected units
1,018

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (17)

  • 1. Catalog Number 440576 (UDI Number 004035479160524) Lot Numbers: M18A1010
  • M18A1022
  • M18C1070
  • M18G1185
  • 2. Catalog Number 440577 (UDI Number 004035479160531) Lot Number M18A1021
  • 3. Catalog Number 440578 (UDI Number 004035479160548) Lot Numbers: M18A1008
  • M18B1051
  • M18G1181
  • 4. Catalog Number 440579 (UDI Number 004035479160555) Lot Numbers: M18F1146
  • M18G1188
  • 5. Catalog Number 440622 (UDI Number 004035479160616) Lot Numbers: M18A1007
  • M18D1080
  • 6. Catalog Number 440623 (UDI Number 004035479160623) Lot Numbers: M18A1015
  • M18C1071
  • 7. Catalog Number 440625 (UDI Number 004035479160647) Lot Number M18G1189
  • 8. Catalog Number 440626 (UDI Number 004035479160654) Lot Numbers: M18A1014
  • M18B1054

Distribution

Distributed nationwide across the United States.

The notice also names 30 states specifically:

Part of a larger recall action

This product is one of 2 recalled by AZIYO BIOLOGICS under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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