AROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 10x12cm devices because the suture material degraded, causing them to fail burst specifications after 18 months.
What this means for you
Illness, injury, or structural failure has been reported. 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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly when involving structural integrity failures in medical devices.
Plain-English summary
AROA Biosurgery, LTD. is recalling 881 units of OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G. 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.
The agency has classified this as a Class II recall. Consumers and healthcare providers should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012G
- 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-6D06
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
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