FDA-Device2018-11-21Class II
OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G
AROA Biosurgery, LTD.
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.
Sold states
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
Affected count
881 total
Manufactured in
69 Gracefield Road, Lower Hutt, New Zealand
Products
OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0416-2019Don't want to check this manually?
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