FDAFDA · Food and drugs·Recall number Z-0421-2019
OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G
Published November 21, 2018 · Recall initiated: April 6, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Visit
Recall details
- Manufacturer
- AROA Biosurgery, LTD.
- Distributor
- The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
- Lot
- ERT-6G10
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- New Zealand
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