AROA Biosurgery recalls OviTex 1S Reinforced BioScaffold 6x10cm (Part F10256-0610G) due to potential degradation of the 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 6x10cm devices because they may degrade after 18 months, potentially weakening the mesh. This could lead to device failure during surgery if the mesh is not strong enough to support tissue layers.
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 to support tissue layers, potentially leading to device failure during surgery.
Patients who received the OviTex 1S Reinforced BioScaffold 6x10cm device during surgery are likely affected. Surgeons using this device for procedures involving tissue layers are at the highest risk.
Check for the product name 'OviTex 1S Reinforced BioScaffold 6x10cm' and part number F10256-0610G. Devices sold with ERT-6K05 or ERT-7J10 labels are also affected.
Look for the product name and part number on the device or packaging to confirm if it is recalled.
The recall indicates that devices over 18 months may not meet the required strength specifications, so they are not safe for use after this period.
The recall does not specify a remedy, so contact the manufacturer directly for guidance.
Check for the product name 'OviTex 1S Reinforced BioScaffold 6x10cm' and part number F10256-0610G, or ERT-6K05/ERT-7J10 labels.
We’ve drafted a message you can send AROA Biosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0422-2019 — AROA Biosurgery AROA Biosurgery Hello, I own a AROA Biosurgery that is covered by recall Z-0422-2019 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.
