FDA Device recall Z-0422-2019
OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G
- FDA Device
- Class II
- terminated
- Published 2018-11-21
On 2018-11-21 the FDA classified a Class II recall of OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G by Aroa Biosurgery, citing 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 indica….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0422-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-04-06 |
| Published | 2018-11-21 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Aroa Biosurgery |
| Distribution | AL, CA, FL, IN, MA, MI, NH, NY |
Product
OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610G
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.
Identifiers
| code_info | ERT-6K05 ERT-7J10 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0422-2019%22
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