OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
Class I - DangerousWhat Should You Do?
- Check if you have this product: ERT-6H16 ERT-6K01 ERT-7J06 ERT-7L15
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- AROA Biosurgery, LTD.
- 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.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
Product Codes/Lot Numbers:
ERT-6H16 ERT-6K01 ERT-7J06 ERT-7L15
Distribution:
Distributed in: US, AL, CA, FL, IN, MA, MI, NH, NY
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0435-2019
Related Recalls
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AROA Biosurgery
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.
OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G
AROA Biosurgery
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.
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.