AZIYO BIOLOGICS recalls CanGaroo Envelopes (Large, Medium, Extra Large, Extra Extra Large) due to possible suture brittleness or breakage along the envelope seam before expiration. Affected units include specific catalog numbers and lot numbers.
Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
AZIYO BIOLOGICS is recalling CanGaroo Envelopes (Large, Medium, Extra Large, and Extra Extra Large) because the envelopes might become brittle or break along the seam before the product's expiration date. This could lead to improper securing of cardiac implants or neurostimulators, potentially causing complications during medical procedures.
The envelopes are designed to hold medical implants securely. If the suture along the envelope seam breaks before the expiration date, it could compromise the stability of the implant during surgery or implantation, potentially leading to device displacement or malfunction.
Patients using CanGaroo Envelopes with cardiac implantable electronic devices (like pacemakers) or implantable neurostimulators (like vagus nerve stimulators) are most at risk. The recall affects specific product sizes and lot numbers.
Check for CanGaroo Envelopes labeled as Large, Medium, Extra Large, or Extra Extra Large. Look for catalog numbers CMCV-009-LRG, CMCV-009-MED, CMCV-009-XLG, CMCV-009-XXL, CMCV-010-LRG, CMCV-010-MED, CMCV-010-XLG, or CMCV-010-XXL with specific lot numbers listed in the recall.
Identify your CanGaroo Envelope model and lot number by checking the catalog number and lot numbers listed in the recall notice.
The recall is due to possible suture brittleness or breakage along the envelope seam before the expiration date, which could compromise the secure holding of medical implants.
CanGaroo Envelopes labeled as Large, Medium, Extra Large, or Extra Extra Large with specific catalog numbers and lot numbers listed in the recall notice.
The recall does not require immediate action; however, you should check your product details against the list provided to ensure you have an affected unit.
We’ve drafted a message you can send AZIYO BIOLOGICS to request your refund or repair — edit it as you like.
Subject: Recall Z-0040-2020 — AZIYO BIOLOGICS AZIYO BIOLOGICS Hello, I own a AZIYO BIOLOGICS that is covered by recall Z-0040-2020 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.
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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.
