Date Initiated by Firm |
April 06, 2018 |
Create Date |
November 09, 2018 |
Recall Status1 |
Terminated 3 on April 15, 2019 |
Recall Number |
Z-0424-2019 |
Recall Event ID |
81166 |
510(K)Number |
K153633
|
Product Classification |
Mesh, surgical - Product Code FTM
|
Product |
OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020G
|
Code Information |
ERT-6J08 ERT-7J08 ERT-7K08 |
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 2 |
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 and Original Applicant = Aroa Biosurgery Limited (Formerly Mesynthes Limited)
|