FDA recall Z-0435-2019

Product

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

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.

Distribution

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

Key facts

Status

Terminated

Initiation date

2018-04-06

Report date

2018-11-21

Termination date

2019-04-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Lower Hutt, New Zealand

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0435-2019