AROA Biosurgery recalls OviTex Reinforced BioScaffold 4x8cm (Part F10254-0408G) 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 4x8cm 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 no longer meet the required strength for tissue layers, potentially leading to improper healing or complications during surgery.
Surgical patients and healthcare providers using the OviTex Reinforced BioScaffold 4x8cm devices. Those with devices over 18 months old are most at risk.
Check for the part number F10254-0408G on the device. The product was sold under ERT-6E12 and ERT-7F02 labels.
Verify if the device has been in use for more than 18 months.
The suture material degrades over time, especially after 18 months, which can cause the device to fail in tissue layers.
Check if the device has been in use for more than 18 months. If so, contact AROA Biosurgery for further guidance.
The recall record does not specify a remedy or fix.
We’ve drafted a message you can send AROA Biosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0415-2019 — AROA Biosurgery AROA Biosurgery Hello, I own a AROA Biosurgery that is covered by recall Z-0415-2019 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.
