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U.S. Department of Health and Human Services

Class 2 Device Recall OviTex 2S Reinforced BioScaffold 6x10cm

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  Class 2 Device Recall OviTex 2S Reinforced BioScaffold 6x10cm see related information
Date Initiated by Firm April 06, 2018
Create Date November 09, 2018
Recall Status1 Terminated 3 on April 15, 2019
Recall Number Z-0428-2019
Recall Event ID 81166
510(K)Number K153633  
Product Classification Mesh, surgical - Product Code FTM
Product OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G

Code Information ERT-6G11 
Recalling Firm/
AROA Biosurgery, LTD.
69 Gracefield Road
Lower Hutt New Zealand
Manufacturer 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.
FDA Determined
Cause 2
Action Beginning in April 2018, customers were visited by representatives and the affected units were replaced.
Quantity in Commerce 881 total
Distribution The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FTM and Original Applicant = Aroa Biosurgery Limited (Formerly Mesynthes Limited)