AROA Biosurgery recalls OviTex Reinforced BioScaffold 16x20cm (Part F10254-1620G) due to potential mesh failure after 18 months of use. Devices may not meet strength requirements for tissue layers.
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers.
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 16x20cm devices because they may weaken after 18 months of use, risking failure during surgery. This could lead to inadequate support for tissue layers, potentially causing complications.
The mesh devices may degrade over time, losing strength needed to support tissue layers. After 18 months, they might not meet the required burst strength for the number of tissue layers they're designed to handle.
Surgical patients and medical professionals using the OviTex Reinforced BioScaffold 16x20cm (Part Number F10254-1620G) for procedures. Those with devices over 18 months old are most at risk.
Check for the part number F10254-1620G on the device. The product was sold under ERT-6G08 or ERT-6J03 labels.
Verify if the device has been in use for more than 18 months.
The devices may weaken after 18 months of use, potentially failing during surgery and not meeting strength requirements for tissue layers.
The official recall notice does not specify a remedy or action for affected devices.
Look for the part number F10254-1620G or the ERT-6G08/ERT-6J03 labels on the device.
We’ve drafted a message you can send AROA Biosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0419-2019 — AROA Biosurgery AROA Biosurgery Hello, I own a AROA Biosurgery that is covered by recall Z-0419-2019 from AROA Biosurgery. 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.
