AROA Biosurgery recalls OviTex 1S Reinforced BioScaffold 10x12cm (Part F10256-1012G) 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 1S Reinforced BioScaffold 10x12cm devices because they may degrade after 18 months, potentially failing to meet tissue layer requirements. This could lead to improper surgical support if used beyond the stability period.
The suture material in these devices degrades over time, especially after 18 months. This degradation can cause the device to fail in supporting tissue layers during surgery, potentially leading to inadequate surgical outcomes.
Surgical patients and healthcare providers who have received the OviTex 1S Reinforced BioScaffold 10x12cm devices with part number F10256-1012G. Those using the product beyond 18 months are at slightly higher risk.
Check for the part number F10256-1012G on the device. The product was sold under model codes ERT-6E05, ERT-6E06, or ERT-7K02.
Verify the part number on the device to confirm it matches F10256-1012G.
The product may degrade after 18 months, potentially failing to meet tissue layer requirements during surgery.
Check the part number on the device; if it matches F10256-1012G, it may need verification due to potential degradation after 18 months.
The recall record does not specify a remedy or fix for this product.
We’ve drafted a message you can send AROA Biosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0423-2019 — AROA Biosurgery AROA Biosurgery Hello, I own a AROA Biosurgery that is covered by recall Z-0423-2019 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.
