Recall Z-0432-2019— AROA Biosurgery, LTD.

Name: FDA recall Z-0432-2019
Creator: U.S. Food and Drug Administration
Published: 2018-04-06

Class II · Terminated

Class II FDA medical device recall by AROA Biosurgery, LTD., initiated 2018-04-06, terminated 2019-04-15. It names one FDA 510(k) clearance: K153633. Product: OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G. Reason: 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..

Recalling firm: AROA Biosurgery, LTD.
Classification: Class II
Status: Terminated
Initiated: 2018-04-06
Terminated: 2019-04-15
Firm location: Lower Hutt, New Zealand

510(k) clearances named in this recall

1 on FDA's record

K153633 — Endoform Reconstructive TemplateAroa Biosurgery Limited (Formerly Mesynthes Limited)·cleared 2016-03-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.