AROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 20x20cm devices because the suture material degraded, causing them to fail burst specifications after 18 months.
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 involves a structural defect (degradation of suture material) in a medical device that could lead to failure during use, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
AROA Biosurgery, LTD. is recalling OviTex Reinforced BioScaffold 20x20cm devices, Part Number F10254-2020G. The recall involves 881 units that were distributed to healthcare facilities in Alabama, California, Florida, Indiana, Massachusetts, Michigan, New Hampshire, and New York.
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.
Healthcare providers should stop using the affected devices and contact AROA Biosurgery for further instructions. Consumers who have received these devices should contact their healthcare provider or the manufacturer for guidance.
The recalled product
- Product
- OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020G
- 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-6H13
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
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- SevereAROA Biosurgery Recalls OviTex 1S Reinforced BioScaffold Mesh Devices
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- HighAROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices
FDA (Devices) · 2018-11-21
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