medical Class II Updated 2018-11-21

AROA Biosurgery, LTD. recalls OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258

Recalled Product

OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G

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-6H16
View official government recall

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