Recall Z-0425-2019
AROA Biosurgery, LTD. · initiated April 6, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
OviTex 1S Reinforced BioScaffold 16x20cm, Part Number F10256-1620G
Codes / lots: ERT-6H14 ERT-6J11 ERT-7K09 ERT-7L13
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 taken
Beginning in April 2018, customers were visited by representatives and the affected units were replaced.
Details
- Recall number
- Z-0425-2019
- Initiated
- April 6, 2018
- Terminated
- April 15, 2019
- Product code
- FTM – Mesh, Surgical
- Quantity
- 881 total
- Distribution
- The products were distributed to the following US states: AL, CA, FL, IN, MA, MI, NH, and NY.
- Recalling firm
- AROA Biosurgery, LTD., Lower Hutt
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0415-2019 Class II | OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0416-2019 Class II | OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0417-2019 Class II | OviTex Reinforced BioScaffold 10x12cm, Part Number F10254-1012GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0418-2019 Class II | OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0419-2019 Class II | OviTex Reinforced BioScaffold 16x20cm, Part Number F10254-1620GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0420-2019 Class II | OviTex Reinforced BioScaffold 20x20cm, Part Number F10254-2020GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0421-2019 Class II | OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0422-2019 Class II | OviTex 1S Reinforced BioScaffold 6x10cm, Part Number F10256-0610GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0423-2019 Class II | OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0424-2019 Class II | OviTex 1S Reinforced BioScaffold 10x20cm, Part Number F10256-1020GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0426-2019 Class II | OviTex 1S Reinforced BioScaffold 18x22cm, Part Number F10256-1822GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0427-2019 Class II | OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0428-2019 Class II | OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0429-2019 Class II | OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0430-2019 Class II | OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0431-2019 Class II | OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0432-2019 Class II | OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0433-2019 Class II | OviTex 2S Reinforced BioScaffold 20x20cm, Part Number F10258-2020GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0434-2019 Class II | OviTex Reinforced BioScaffold 18x22cm, Part Number F10254-1822GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |
| Z-0435-2019 Class II | OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012GDegradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed… | 04/06/2018Terminated |