AROA Biosurgery, LTD.: Medical Device Recall in 2018 - (Recall #: Z-0435-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: April 6, 2018

Date Posted: November 21, 2018

Recall Number: Z-0435-2019

Event ID: 81166

Reason for Recall:

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.

Status: Terminated

Product Quantity: 881 total

Code Information:

ERT-6H16 ERT-6K01 ERT-7J06 ERT-7L15

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated