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AROA Biosurgery, LTD. recalls OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G
Recalled November 21, 2018 · FDA recall Z-0424-2019 · AROA Biosurgery
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. · FDA Class II
Units
881 total
Sold at
The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
Description
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.
Product
OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G
Manufacturer(s)
AROA Biosurgery, LTD.
Made in
New Zealand
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →