OviTex Reinforced BioScaffold 16x20cm — Class II medical device recall Z-0419-2019
Terminated recall by AROA Biosurgery, LTD., reported 2018-11-21, distributed in AL, CA, FL, IN, MA, MI, NH, NY. Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed dur
| Recall number | Z-0419-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | AROA Biosurgery, LTD., Lower Hutt, New Zealand |
| Recall initiated | 2018-04-06 |
| Classified | 2018-11-09 |
| Reported by FDA | 2018-11-21 |
| Terminated | 2019-04-15 |
| Distributed | AL, CA, FL, IN, MA, MI, NH, NY |
| Quantity | 881 total |
| Reason classes | specification failure |
| Model numbers | F10254-1620G |
Product
OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0419-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.