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 some units to fail burst specifications.
What this means for you
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 defect (failure to meet burst specifications) in a medical device 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 1S Reinforced BioScaffold 10x20cm (Part Number F10256-1020G). 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-6J08, ERT-7J08, and ERT-7K08.
Healthcare providers and facilities should stop using the affected devices and contact AROA Biosurgery for instructions on return or disposal. Patients who have already received these devices should consult their healthcare provider if they have concerns about the integrity of the implant.
The recalled product
- Product
- OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G
- 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-6J08 ERT-7J08 ERT-7K08
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.
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FDA (Devices) · 2018-11-21
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- HighAROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices
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