Z-0435-2019 Class II Terminated
FDA device recall Z-0435-2019 was initiated by AROA Biosurgery, LTD. on Apr 6, 2018 and is designated Class II. 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… The recall status is terminated (terminated Apr 15, 2019). Affected quantity: 881 total.
Recall details
- Product Type
- Devices
- Report Date
- Nov 21, 2018
- Initiation Date
- Apr 6, 2018
- Termination Date
- Apr 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 881 total
Product description
OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
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 pattern
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
Code information
ERT-6H16 ERT-6K01 ERT-7J06 ERT-7L15
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0435-2019
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026