Z-0427-2019 Class II Terminated
FDA device recall Z-0427-2019 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 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G
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-6H01 ERT-6H15 ERT-7J02 ERT-7L02 ERT-7L10
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0427-2019
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026