AROA Biosurgery Recalls OviTex 2S Reinforced BioScaffold 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 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 OviTex 2S Reinforced BioScaffold 6x10cm devices, Part Number F10258-0610G. 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 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.
Healthcare providers and facilities should stop using the affected devices and contact AROA Biosurgery for instructions on return or replacement. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G
- 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-6G11
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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