AROA Biosurgery, LTD. recalls OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G

Recall date

April 6, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0416-2019

FDA classification

Class II

Brand / firm

AROA Biosurgery, LTD.

Sold / distributed

The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G