AROA Biosurgery Recalls OviTex 2S Reinforced BioScaffold Mesh Devices
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold 10x12cm devices because the suture material degraded, causing them to fail burst specifications.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that failed to meet pre-defined burst specifications, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
AROA Biosurgery, LTD. is recalling 881 units of OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G. The recall was initiated after an ongoing product stability study observed degradation in the PGA suture material used to manufacture these resorbable mesh devices.
Further investigation revealed that devices older than 18 months showed evidence of no longer meeting the pre-defined ball burst specification relative to the number of tissue layers. The affected products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
Healthcare providers and patients should stop using the recalled devices and contact AROA Biosurgery, LTD. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
- Manufacturer
- AROA Biosurgery, LTD.
- Category
- Medical Device — Resorbable Mesh
- Affected units
- 881
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- ERT-6H16
Distribution
Part of a larger recall action
This product is one of 21 recalled by AROA Biosurgery, LTD. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 21 products in this recall →Related recalls
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