AROA Biosurgery Recalls OviTex 2S Reinforced BioScaffold Mesh Devices
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold mesh devices because the suture material degraded, causing them to fail burst specifications.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 product 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 the OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G. The recall is due to the degradation of the PGA suture material used in the manufacture of these resorbable mesh devices.
During an ongoing product stability study, it was observed that devices older than 18 months showed evidence of no longer meeting the pre-defined ball burst specification regarding the number of tissue layers. The affected products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
The specific lot codes associated with this recall are ERT-6E01, ERT-6I01, and ERT-6J07. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled devices.
The recalled product
- Product
- OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G
- 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-6E01 ERT-6I01 ERT-6J07
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
Same manufacturer · AROA Biosurgery, LTD.
See all →- HighAROA Biosurgery Recalls OviTex 2S Reinforced BioScaffold Mesh Devices
FDA (Devices) · 2018-11-21
- HighAROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices
FDA (Devices) · 2018-11-21
- HighAROA Biosurgery Recalls OviTex 1S Reinforced BioScaffold Devices
FDA (Devices) · 2018-11-21
- SevereAROA Biosurgery Recalls OviTex 1S Reinforced BioScaffold Mesh Devices
FDA (Devices) · 2018-11-21
- HighAROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices
FDA (Devices) · 2018-11-21
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