AROA Biosurgery recalls OviTex 2S Reinforced BioScaffold 20x20cm (Part F10258-2020G) due to potential degradation of suture material after 18 months, which may affect device strength.
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 2S Reinforced BioScaffold 20x20cm devices that may degrade after 18 months, potentially weakening the mesh. This could lead to device failure during surgery if not properly anchored.
The suture material in the mesh degrades over time, especially after 18 months. This degradation can cause the device to no longer meet strength requirements for the number of tissue layers it's designed to support, potentially leading to failure during surgery.
Surgical patients and medical professionals using the OviTex 2S Reinforced BioScaffold 20x20cm devices. Those who have used the product beyond 18 months are at slightly higher risk of device failure.
Check for the product name 'OviTex 2S Reinforced BioScaffold 20x20cm' and part number F10258-2020G. Devices sold with ERT-6I04, ERT-6I05, ERT-6J12, ERT-6K01, ERT-7J06, or ERT-7L15 labels are also affected.
Verify if the device has been used for more than 18 months.
Reach out to AROA Biosurgery for specific guidance on device safety.
The recall indicates that devices over 18 months may not meet strength requirements, so they are not recommended for use beyond this period.
Check the device age and contact AROA Biosurgery for specific guidance on safety and next steps.
Look for the product name 'OviTex 2S Reinforced BioScaffold 20x20cm' and part number F10258-2020G, or ERT-6I04 through ERT-7L15 labels.
We’ve drafted a message you can send AROA Biosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0433-2019 — AROA Biosurgery AROA Biosurgery Hello, I own a AROA Biosurgery that is covered by recall Z-0433-2019 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.
