Recall Z-0427-2019 ยท FTM Mesh, Surgical
AROA Biosurgery, LTD.
OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G
| Date | Apr 6, 2018 |
| 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. |
| Root cause | Other |
| Action | Beginning in April 2018, customers were visited by representatives and the affected units were replaced. |
| Quantity | 881 total |
| Distribution | The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K153633 | Endoform Reconstructive Template Aroa Biosurgery Limited (Formerly Mesynthes Limited), Mar 15, 2016 |