AROA recalls OviTex 1S Reinforced BioScaffold 10x20cm devices that may degrade after 18 months, potentially failing to meet tissue layer specifications. Affected units include specific part numbers and model codes.
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 is recalling OviTex 1S Reinforced BioScaffold 10x20cm devices that may degrade after 18 months. This could cause the mesh to fail to meet tissue layer requirements, potentially leading to improper surgical outcomes.
The PGA suture material in the mesh degrades over time. After 18 months, the mesh may not meet the required strength for the number of tissue layers it's designed to support, potentially causing surgical complications.
Surgical professionals using the OviTex 1S Reinforced BioScaffold 10x20cm for procedures. Those with devices over 18 months old are most at risk.
Check for part number F10256-1020G or model codes ERT-6J08, ERT-7J08, or ERT-7K08. Devices purchased after the product's release date are likely affected if over 18 months old.
Verify if the device has been in use for more than 18 months.
The recall is due to observed degradation of the PGA suture material in devices over 18 months, which may cause the mesh to fail tissue layer specifications.
Part number F10256-1020G and model codes ERT-6J08, ERT-7J08, and ERT-7K08.
No immediate stop is required; check if the device is over 18 months old before considering action.
We’ve drafted a message you can send AROA Biosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0424-2019 — AROA Biosurgery AROA Biosurgery Hello, I own a AROA Biosurgery that is covered by recall Z-0424-2019 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.
