AROA Biosurgery recalls OviTex 2S Reinforced BioScaffold 10x12cm (Part F10258-1012G) due to potential degradation after 18 months, risking failure in tissue layers. Affected units sold with ERT-6H16, ERT-6K01, ERT-7J06, or ERT-7L15 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 Biosurgery is recalling OviTex 2S Reinforced BioScaffold 10x12cm devices because they may degrade after 18 months, potentially failing in tissue layers. This could lead to improper healing or complications during surgery.
The PGA suture material in the device degrades over time, and devices older than 18 months may not meet the required strength to support tissue layers. This could cause the device to fail during surgery, leading to improper healing or complications.
Surgical patients who received the OviTex 2S Reinforced BioScaffold 10x12cm (Part Number F10258-1012G) from 2022 to 2024. Surgeons and medical facilities using these devices are most at risk.
Check for the part number F10258-1012G and the ERT codes ERT-6H16, ERT-6K01, ERT-7J06, or ERT-7L15 on the device packaging or label. These units were sold between 2022 and 2024.
Identify the part number and ERT codes on the device packaging or label to confirm if it is recalled.
The OviTex 2S Reinforced BioScaffold 10x12cm may degrade after 18 months, potentially failing in tissue layers during surgery.
Check the part number and ERT codes on the device packaging or label to confirm if it is recalled. If it matches, contact AROA Biosurgery for further instructions.
The recall covers devices sold between 2022 and 2024.
We’ve drafted a message you can send AROA Biosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0435-2019 — AROA Biosurgery AROA Biosurgery Hello, I own a AROA Biosurgery that is covered by recall Z-0435-2019 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.
