FDAApril 6, 2018device
OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620G
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
aroa biosurgeryaroa
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDAEndoform Dermal Template 4x5, SKU 529313 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.2018-11-27
- FDAEndoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.2018-11-27
- FDAEndoform Dermal Template 2x2, SKU 529311 Product Usage: Endoform Dermal Template is a sterile, single use ovine forestomach derived extracellular matrix intended to cover, protect and provide a moist wound environment.2018-11-27
- FDAOviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G2018-04-06
- FDAOviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G2018-04-06
- FDAOviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G2018-04-06
- FDAOviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G2018-04-06
- FDAOviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G2018-04-06
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