# FDA recall Z-0428-2019

> **AROA Biosurgery, LTD.** · Class II · device recall initiated 2018-04-06.

## Product

OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G

## 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.

## Distribution

The products were distributed to the following US states:  AL, CA, FL, IN, MA, MI, NH, and NY.

## Key facts

- **Recall number:** Z-0428-2019
- **Recalling firm:** AROA Biosurgery, LTD.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-06
- **Report date:** 2018-11-21
- **Termination date:** 2019-04-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lower Hutt, New Zealand

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0428-2019

## Citation

> AI Analytics. FDA recall Z-0428-2019. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/Z-0428-2019. Source: US FDA. Licensed CC0.

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