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Recall Observatory FDA recall evidence

Device product

OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G

Z-0419-2019

April 06, 2018

Class II

Product summary

Firm
AROA Biosurgery, LTD.
Event
Event 81166
Status
Terminated
Classification
Class II
Quantity
881 total
Official record key
device-enforcement:Z-0419-2019

Official wording

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.

Code information: ERT-6G08 ERT-6J03

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.