Class II — AROA Biosurgery, LTD.
| Recalling firm | Aroa Biosurgery Ltd |
|---|---|
| Registered facility | Aroa Biosurgery Ltd (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. Further investigation indicated that devices over 18-months showed evidence of no longer meeting the pre-defined ball burst specification respective to the number of tissue layers. |
| Product | OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G |
| Quantity | 881 total |
| Distribution | The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. |
| Initiated | 2018-04-06 |
| Classified | 2018-11-09 |
| Terminated | 2019-04-15 |
| Recall number | Z-0424-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — AROA Biosurgery, LTD. (Z-0424-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81166/
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