AROA Biosurgery recalls OviTex Reinforced BioScaffold 10x12cm (Part F10254-1012G) due to potential degradation of the PGA suture material after 18 months, risking failure in 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 10x12cm devices because they may degrade after 18 months, potentially failing to meet tissue layer requirements. This could lead to improper surgical support if used beyond the stability period.
The PGA suture material in the mesh devices degrades over time. After 18 months, the devices may not meet the required strength to support tissue layers, potentially causing surgical complications.
Surgical professionals using the OviTex Reinforced BioScaffold 10x12cm (Part Number F10254-1012G) for procedures. Those using devices over 18 months are most at risk of potential failure.
Check for the part number F10254-1012G on the device. The product was sold with the ERT-6D06 identifier. Devices used for more than 18 months are at higher risk.
Verify if the device has been used for more than 18 months.
The recall is due to potential degradation of the PGA suture material after 18 months, which may cause the device to fail in supporting tissue layers.
The official recall notice does not specify a remedy, so no action is required unless the device is over 18 months old.
The recall indicates potential failure after 18 months, but no specific injury mechanism is described. This is considered low risk.
We’ve drafted a message you can send AROA Biosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0417-2019 — AROA Biosurgery AROA Biosurgery Hello, I own a AROA Biosurgery that is covered by recall Z-0417-2019 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.
