AROA Biosurgery Recalls OviTex 1S Reinforced BioScaffold Mesh Devices
AROA Biosurgery is recalling OviTex 1S 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source describes a structural defect (failure to meet burst specifications) in a medical device, which aligns with the 'Severe' criteria for structural defects or significant injury risks.
Plain-English summary
AROA Biosurgery, LTD. is recalling 881 units of OviTex 1S Reinforced BioScaffold 18x22cm (Part Number F10256-1822G). The recall was initiated after an ongoing product stability study observed 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: AL, CA, FL, IN, MA, MI, NH, and NY. The specific lot codes involved are ERT-6D08, ERT-6J06, ERT-7L03, and ERT-7L16.
Healthcare providers and patients should check their inventory or medical records for these specific part numbers and lot codes. If the product is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822G
- 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-6D08 ERT-6J06 ERT-7L03 ERT-7L16
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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- HighAROA Biosurgery Recalls OviTex 1S Reinforced BioScaffold Devices
FDA (Devices) · 2018-11-21
- HighAROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices
FDA (Devices) · 2018-11-21
- HighAROA Biosurgery Recalls OviTex 2S Reinforced BioScaffold Mesh Devices
FDA (Devices) · 2018-11-21
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