AROA Biosurgery recalls OviTex 2S Reinforced BioScaffold 18x22cm (Part F10258-1822G) 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 2S Reinforced BioScaffold 18x22cm devices because they may degrade after 18 months, potentially failing in tissue layers. This could lead to improper healing or complications during surgery.
The suture material in the device degrades over time, especially after 18 months. This degradation can cause the device to fail in supporting tissue layers, potentially leading to improper healing or complications during surgery.
Surgical patients using the OviTex 2S Reinforced BioScaffold 18x22cm device for procedures. Patients who have had the device implanted over 18 months are most at risk.
Check for the product name 'OviTex 2S Reinforced BioScaffold 18x22cm' and part number F10258-1822G. Devices sold under ERT-6E01, ERT-6I01, or ERT-6J07 are also affected.
Look for the product name and part number on the device packaging or label.
The suture material degrades over time, especially after 18 months, which can cause the device to fail in supporting tissue layers.
The recall does not specify a remedy, so contact the manufacturer for guidance.
The product is designed to last up to 18 months before potential degradation occurs.
We’ve drafted a message you can send AROA Biosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0432-2019 — AROA Biosurgery AROA Biosurgery Hello, I own a AROA Biosurgery that is covered by recall Z-0432-2019 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.
