Class 2 Device Recall OviTex 2S Reinforced BioScaffold 10x12cm

• Date Initiated by Firm: April 06, 2018
• Create Date: November 09, 2018
• Recall Status: Terminated on April 15, 2019
• Recall Number: Z-0435-2019
• Recall Event ID: 81166
• 510(K)Number: K153633
• Product Classification: Mesh, surgical - Product Code FTM
• Product: OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
• Code Information: ERT-6H16 ERT-6K01 ERT-7J06 ERT-7L15
• Recalling Firm/ Manufacturer: 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: Other
• 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