AROA Biosurgery Recalls OviTex 1S Reinforced BioScaffold Mesh Devices
AROA Biosurgery is recalling OviTex 1S Reinforced BioScaffold 16x20cm devices because the PGA 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 with a structural defect (failure to meet burst specifications) where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
AROA Biosurgery, LTD. is recalling 881 units of the OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G. 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 determined 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 healthcare facilities in Alabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire, and New York.
Healthcare providers and patients should stop using the affected devices. The specific lot codes associated with this recall are ERT-6H14, ERT-6J11, ERT-7K09, and ERT-7L13. Users should contact AROA Biosurgery for further instructions on returning or disposing of the product.
The recalled product
- Product
- OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G
- Manufacturer
- AROA Biosurgery, LTD.
- Category
- Medical Device — Surgical 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-6H14 ERT-6J11 ERT-7K09 ERT-7L13
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
Same hazard · structural defect
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