AZIYO BIOLOGICS recalls BioEnvelope surgical mesh envelopes due to possible suture brittleness or breakage before expiration. Affected units include specific sizes and lot numbers; contact for remedy.
Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
AZIYO BIOLOGICS is recalling BioEnvelope surgical mesh envelopes because they may become brittle or break along the seam before the product expires. This could lead to improper implantation of cardiac devices, posing a risk during surgery.
The BioEnvelope is designed to hold cardiac implants securely during surgery. If the suture along the seam breaks before the product expires, it could cause the implant to become unstable or dislodge during the procedure, potentially leading to complications.
Patients who have received BioEnvelope surgical mesh envelopes for cardiac implantable electronic devices, such as pacemakers or defibrillators, are most at risk. The recall affects specific sizes and lot numbers of the envelopes.
Check the product label for the size (Medium, Large, Extra Large, or Extra Extra Large) and the lot number (e.g., M18A1010, M18G1185). The catalog number and UDI number are also listed on the packaging.
Look for the size (Medium, Large, Extra Large, or Extra Extra Large) and lot number on the BioEnvelope packaging.
Reach out to AZIYO BIOLOGICS for specific instructions on how to return or replace the affected units.
The BioEnvelope may experience suture brittleness or breakage along the seam before the expiration date, which could lead to improper implantation of cardiac devices.
Affected lot numbers include M18A1010, M18A1022, M18C1070, M18G1185, M18A1021, M18A1008, M18B1051, M18G1181, M18F1146, M18G1188, M18A1007, M18D1080, M18A1015, M18C1071, M18G1189, and M18A1014, M18B1054.
Check the product label for the size (Medium, Large, Extra Large, or Extra Extra Large) and the specific lot number listed in the recall notice.
We’ve drafted a message you can send AZIYO BIOLOGICS to request your refund or repair — edit it as you like.
Subject: Recall Z-0039-2020 — AZIYO BIOLOGICS AZIYO BIOLOGICS Hello, I own a AZIYO BIOLOGICS that is covered by recall Z-0039-2020 from AZIYO BIOLOGICS. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
