AROA Biosurgery recalls OviTex Reinforced BioScaffold 20x20cm (Part F10254-2020G) due to potential degradation of the PGA 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 Reinforced BioScaffold 20x20cm devices because they may degrade after 18 months, weakening the mesh and potentially causing failure during use. This could lead to complications if the device is used beyond its intended lifespan.
The PGA suture material in the mesh can degrade 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 surgery.
Medical professionals who use this device for surgical procedures are most at risk if they have the recalled model. Patients using the device are not directly affected by the recall.
Check for the product name 'OviTex Reinforced BioScaffold 20x20cm' and part number F10254-2020G. The device may also have the ERT-6H13 identifier.
Look for the product name and part number on the device to confirm if it is recalled.
The recall indicates that devices over 18 months may not meet strength requirements, so they are not recommended for continued use.
The recall does not specify a remedy, so contact the manufacturer for guidance.
Check for the product name 'OviTex Reinforced BioScaffold 20x20cm' and part number F10254-2020G.
We’ve drafted a message you can send AROA Biosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0420-2019 — AROA Biosurgery AROA Biosurgery Hello, I own a AROA Biosurgery that is covered by recall Z-0420-2019 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.
