Lower Hutt, New Zealand
AROA Biosurgery, LTD. recalls
2 recalls recorded since 2018, most recently on 27 November 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)0
Terminated or completed2
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 27 November 2018
- Terminated
- 9 April 2019
- Reason
- Potential for pouch seal failure
- Distribution
- US Nationwide Distribution
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0378-2019, Z-0377-2019, Z-0379-2019
- Endoform 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 environmen
- Endoform 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 environmen
- Endoform 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 environmen
Terminated Class II Medical devices
- Recall started
- 6 April 2018
- Terminated
- 15 April 2019
- 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.
- Distribution
- The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0421-2019, Z-0416-2019, Z-0429-2019, Z-0423-2019, Z-0432-2019, Z-0418-2019, Z-0435-2019, Z-0431-2019, Z-0430-2019, Z-0427-2019, Z-0415-2019, Z-0428-2019 and 9 more
- OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G
- OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G
- OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
- OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G
- OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G
- OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G
- OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
- OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G
- and 13 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.