AROA Biosurgery recalls OviTex 1S Reinforced BioScaffold 20x20cm (Part F10256-2020G) due to potential degradation of the PGA suture material after 18 months, which may affect device strength. Affected units include specific model codes ERT-6H01 through ERT-7L10.
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 20x20cm devices that may degrade after 18 months of use. This degradation could cause the device to no longer meet strength requirements, potentially affecting surgical outcomes.
The PGA suture material in the device degrades over time, and after 18 months, the device may not meet the required strength specifications for the number of tissue layers it's designed to support. This could lead to reduced effectiveness during surgical procedures.
Surgical professionals who use the OviTex 1S Reinforced BioScaffold 20x20cm for procedures. Patients who have received this device are at minimal risk as the issue relates to device degradation over time rather than immediate failure.
Check for the part number F10256-2020G on the device. Affected models include ERT-6H01, ERT-6H15, ERT-7J02, ERT-7L02, and ERT-7L10. These devices were sold with specific model codes.
Look for the part number F10256-2020G or model codes ERT-6H01 through ERT-7L10 on the device.
The recall is due to potential degradation of the PGA suture material after 18 months, which may cause the device to no longer meet strength requirements for surgical use.
The device may not meet the required strength specifications for the number of tissue layers it's designed to support, potentially affecting surgical outcomes.
Check for the part number F10256-2020G or model codes ERT-6H01, ERT-6H15, ERT-7J02, ERT-7L02, or ERT-7L10 on the device.
We’ve drafted a message you can send AROA Biosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0427-2019 — AROA Biosurgery AROA Biosurgery Hello, I own a AROA Biosurgery that is covered by recall Z-0427-2019 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.
