AROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices
AROA Biosurgery is recalling OviTex Reinforced BioScaffold 4x8cm devices because the suture material degraded, causing them 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 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 OviTex Reinforced BioScaffold 4x8cm devices, Part Number F10254-0408G. 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 the 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 instructions on how to return them. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G
- 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-6E12 ERT-7F02
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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- HighAROA Biosurgery Recalls OviTex Reinforced BioScaffold Mesh Devices
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