Z-0423-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 21, 2018
- Initiation Date
- April 6, 2018
- Termination Date
- April 15, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 881 total
Product Description
OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G
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-6E05 ERT-6E06 ERT-7K02