AROA Biosurgery recalls OviTex 2S Reinforced BioScaffold 6x10cm (Part F10258-0610G) due to potential degradation of 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 2S Reinforced BioScaffold 6x10cm devices because they may degrade after 18 months, potentially weakening the mesh. This could lead to device failure during surgery if not properly anchored.
The suture material in the device degrades over time, especially after 18 months. This degradation may cause the device to no longer meet strength requirements for the number of tissue layers it's designed to support, potentially leading to device failure during surgery.
Surgical patients and medical professionals using the OviTex 2S Reinforced BioScaffold 6x10cm devices. Those who have used the product for over 18 months are most at risk.
Check for the product name 'OviTex 2S Reinforced BioScaffold 6x10cm' and part number F10258-0610G. The device may also be labeled with ERT-6G11.
Look for the product name and part number on the device label.
The recall is due to potential degradation of the suture material after 18 months, which may cause the device to no longer meet strength requirements for the number of tissue layers it's designed to support.
The risk increases after 18 months of use, as the suture material may degrade and weaken the device.
The recall does not specify a remedy, so check with the manufacturer for further instructions.
We’ve drafted a message you can send AROA Biosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0428-2019 — AROA Biosurgery AROA Biosurgery Hello, I own a AROA Biosurgery that is covered by recall Z-0428-2019 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.
