AROA Biosurgery recalls OviTex 2S Reinforced BioScaffold 16x20cm (Part F10258-1620G) due to potential degradation of the suture material after 18 months, which may affect device strength. Affected units include ERT-6E14, ERT-6E17, and ERT-8A02 models.
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 16x20cm devices that may degrade after 18 months, potentially weakening the mesh. This could lead to device failure during medical procedures if not properly maintained.
The suture material in the mesh devices degrades over time, especially after 18 months. This degradation may 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 medical procedures.
Surgical patients and medical professionals who use the OviTex 2S Reinforced BioScaffold 16x20cm devices. The risk is highest for those using devices over 18 months old.
Check for the part number F10258-1620G on the device. Affected models include ERT-6E14, ERT-6E17, and ERT-8A02. Devices purchased after the product's release date may be unaffected.
Verify if the device has been in use for more than 18 months.
Reach out to AROA Biosurgery for specific guidance on affected units.
The recall is due to observed degradation of the PGA suture material in devices over 18 months, which may cause the mesh to no longer meet strength requirements for tissue layers.
Affected models include ERT-6E14, ERT-6E17, and ERT-8A02 with part number F10258-1620G.
No immediate stop is required, but devices over 18 months should be checked for potential degradation.
We’ve drafted a message you can send AROA Biosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0431-2019 — AROA Biosurgery AROA Biosurgery Hello, I own a AROA Biosurgery that is covered by recall Z-0431-2019 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.
