AROA Biosurgery Recalls OviTex 2S Reinforced BioScaffold Mesh Devices
AROA Biosurgery is recalling OviTex 2S Reinforced BioScaffold 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 is classified as FDA Class II, and the hazard involves a structural failure (burst specification) of a medical device where no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
AROA Biosurgery, LTD. is recalling 881 units of OviTex 2S Reinforced BioScaffold 20x20cm devices, Part Number F10258-2020G. The recall was initiated after an ongoing product stability study revealed degradation of the PGA suture material used in the manufacture of these resorbable mesh devices.
Further investigation indicated 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: Alabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire, and New York. The specific lot codes involved are ERT-6I04, ERT-6I05, ERT-6J12, ERT-6K01, ERT-7J06, and ERT-7L15.
Healthcare providers and facilities should check their inventory for these specific part numbers and lot codes. If the recalled devices are found, they should be removed from use and returned to the manufacturer or disposed of according to the instructions provided by AROA Biosurgery.
The recalled product
- Product
- OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020G
- 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-6I04 ERT-6I05 ERT-6J12 ERT-6K01 ERT-7J06 ERT-7L15
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
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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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