AROA Biosurgery recalls OviTex Reinforced BioScaffold 10x20cm (Part F10254-1020G) due to potential degradation of suture material after 18 months, risking failure in tissue layers.
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 10x20cm devices because they may degrade after 18 months, potentially failing to meet tissue layer strength requirements. This could lead to improper surgical support if used beyond the recommended timeframe.
The suture material in the device degrades over time, especially after 18 months. This degradation can cause the device to no longer meet the required strength for supporting tissue layers during surgery, potentially leading to inadequate surgical support.
Surgical professionals using OviTex Reinforced BioScaffold 10x20cm devices for procedures. Those who have used the product beyond 18 months are at slightly higher risk of device failure.
Check for the product name 'OviTex Reinforced BioScaffold 10x20cm' and part number F10254-1020G. The device was sold with the ERT-6F02 identifier.
Verify if the device has been in use for more than 18 months.
The recall indicates devices over 18 months may not meet strength requirements, so they should not be used beyond this timeframe.
The recall does not specify a remedy, so contact the manufacturer for guidance on safe disposal or replacement.
Look for the product name 'OviTex Reinforced BioScaffold 10x20cm' and part number F10254-1020G, sold with the ERT-6F02 identifier.
We’ve drafted a message you can send AROA Biosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0418-2019 — AROA Biosurgery AROA Biosurgery Hello, I own a AROA Biosurgery that is covered by recall Z-0418-2019 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.
