AROA Biosurgery recalls OviTex Reinforced BioScaffold 18x22cm (Part F10254-1822G) 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 Reinforced BioScaffold 18x22cm devices because they may degrade after 18 months, potentially weakening the mesh and affecting surgical outcomes. This could lead to device failure during use, though the risk is not immediate.
The suture material in the mesh devices can degrade after 18 months of use, which may cause the device to no longer meet strength requirements for the number of tissue layers it's designed to support. This could lead to device failure during surgery.
Surgical professionals who use the OviTex Reinforced BioScaffold 18x22cm devices are most at risk if the product has been in use for over 18 months.
Check for the part number F10254-1822G on the device. The product was sold under model codes ERT-6D03, ERT-6J05, ERT-6K01, ERT-7J06, and ERT-7L15.
Verify if the device has been in use for more than 18 months.
The suture material may degrade after 18 months, causing the device to no longer meet strength requirements for the number of tissue layers it's designed to support.
The recall does not specify a remedy, so check if the device has been in use for more than 18 months and contact the manufacturer if concerned.
The recall indicates potential device failure after 18 months, but no specific risk of serious injury is mentioned.
We’ve drafted a message you can send AROA Biosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0434-2019 — AROA Biosurgery AROA Biosurgery Hello, I own a AROA Biosurgery that is covered by recall Z-0434-2019 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.
