AROA Biosurgery recalls OviTex 2S Reinforced BioScaffold 10x20cm (Part F10258-1020G) 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 10x20cm devices because they may degrade after 18 months, potentially failing to meet tissue layer requirements. This could lead to improper surgical support during procedures.
The suture material in the device degrades over time, especially after 18 months. This degradation may cause the device to fail in supporting tissue layers during surgery, potentially leading to inadequate surgical outcomes.
Surgical professionals using the OviTex 2S Reinforced BioScaffold 10x20cm devices for procedures. Patients who have received this device are at minimal risk if the device functions properly.
Check for the product name 'OviTex 2S Reinforced BioScaffold 10x20cm' and part number F10258-1020G. Devices sold under ERT-6E16 or ERT-6F01 labels are also affected.
Verify the product name and part number on the device to confirm if it is recalled.
The recall indicates potential degradation after 18 months, but the official notice does not specify if devices beyond this age are safe.
The recall record does not provide specific action steps for affected users.
Check for the product name 'OviTex 2S Reinforced BioScaffold 10x20cm' and part number F10258-1020G, or ERT-6E16/ERT-6F01 labels.
We’ve drafted a message you can send AROA Biosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0430-2019 — AROA Biosurgery AROA Biosurgery Hello, I own a AROA Biosurgery that is covered by recall Z-0430-2019 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.
