AROA Biosurgery recalls OviTex 1S Reinforced BioScaffold 16x20cm devices that may degrade after 18 months, risking failure in tissue layers. Affected units include specific part numbers and model codes.
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 16x20cm devices that may degrade after 18 months, potentially failing in tissue layers. This could lead to improper surgical support if used beyond the stability period.
The PGA suture material in these devices degrades over time, especially after 18 months. This degradation can cause the device to no longer meet the required strength for supporting tissue layers during surgery.
Surgical professionals using the OviTex 1S Reinforced BioScaffold 16x20cm for procedures. Patients who have received this device are at minimal risk if the device was used within the intended time frame.
Check for part number F10256-1620G or model codes ERT-6H14, ERT-6J11, ERT-7K09, ERT-7L13. The device is a 16x20cm reinforced bio-scaffold used in surgical procedures.
Identify the part number or model code on the device to confirm if it is affected.
The PGA suture material degrades over time, especially after 18 months, which can cause the device to fail in supporting tissue layers.
Part number F10256-1620G and model codes ERT-6H14, ERT-6J11, ERT-7K09, ERT-7L13.
The recall record does not specify a remedy.
We’ve drafted a message you can send AROA Biosurgery to request your refund or repair — edit it as you like.
Subject: Recall Z-0425-2019 — AROA Biosurgery AROA Biosurgery Hello, I own a AROA Biosurgery that is covered by recall Z-0425-2019 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.
