AROA Biosurgery recalls OviTex 1S Reinforced BioScaffold 4x8cm (Part F10256-0408G) 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 1S Reinforced BioScaffold 4x8cm devices because they may degrade after 18 months, potentially weakening the mesh. This could lead to device failure during use, though the risk is not immediate.
The suture material in the mesh can degrade over time, especially after 18 months. This degradation may cause the mesh to no longer meet strength requirements for the number of tissue layers it's designed to support.
Patients who received this surgical mesh for procedures like hernia repair are likely affected. Those using the product beyond 18 months face the highest risk.
Check for the part number F10256-0408G on the device or packaging. The product was sold under the ERT-6G10 designation.
Verify the product's manufacture date by looking for the part number F10256-0408G on the device or packaging.
The recall indicates potential degradation after 18 months, but the official notice does not specify if it's safe to use beyond that point.
The recall does not provide a remedy, so no specific action is required beyond checking the product's age.
Look for the part number F10256-0408G on the device or packaging, or check for the ERT-6G10 designation.
We’ve drafted a message you can send AROA Biosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0421-2019 — AROA Biosurgery AROA Biosurgery Hello, I own a AROA Biosurgery that is covered by recall Z-0421-2019 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.
