medical Class II Updated 2018-11-21

AROA Biosurgery, LTD. recalls OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256

Recalled Product

OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G

Hazard / Issue

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.

Issued by

FDA

Affected States: AL, CA, FL, IN, MA, MI, NH, NY
Lot/Code Info: ERT-6H14 ERT-6J11 ERT-7K09 ERT-7L13
View official government recall

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