fda
14 records
FDA Recall: AROA Biosurgery, LTD. — Class II
20181121
Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product stability study. | Product: OviTex 1S Reinforced BioScaffold 4x8cm...
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FDA Device Recall: OviTex 1S Reinforced BioScaffold 4x8cm, Part Number F10256-0408G
2018-11-21
Class II — 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 d...
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FDA Device Recall: OviTex Reinforced BioScaffold 6x10cm, Part Number F10254-0610G
2018-11-21
Class II — 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 d...
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FDA Device Recall: OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
2018-11-21
Class II — 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 d...
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FDA Device Recall: OviTex 1S Reinforced BioScaffold 10x12cm, Part Number F10256-1012G
2018-11-21
Class II — 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 d...
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FDA Device Recall: OviTex 2S Reinforced BioScaffold 18x22cm, Part Number F10258-1822G
2018-11-21
Class II — 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 d...
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FDA Device Recall: OviTex Reinforced BioScaffold 10x20cm, Part Number F10254-1020G
2018-11-21
Class II — 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 d...
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FDA Device Recall: OviTex 2S Reinforced BioScaffold 10x12cm, Part Number F10258-1012G
2018-11-21
Class II — 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 d...
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FDA Device Recall: OviTex 2S Reinforced BioScaffold 16x20cm, Part Number F10258-1620G
2018-11-21
Class II — 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 d...
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FDA Device Recall: OviTex 2S Reinforced BioScaffold 10x20cm, Part Number F10258-1020G
2018-11-21
Class II — 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 d...
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FDA Device Recall: OviTex 1S Reinforced BioScaffold 20x20cm, Part Number F10256-2020G
2018-11-21
Class II — 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 d...
View Source
FDA Device Recall: OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G
2018-11-21
Class II — 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 d...
View Source
FDA Device Recall: OviTex 2S Reinforced BioScaffold 6x10cm, Part Number F10258-0610G
2018-11-21
Class II — 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 d...
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FDA Device Recall: Endoform Dermal Template 2x2, SKU 529312 Product Usage: Endoform Dermal Temp
2018-11-14
Class II — Potential for pouch seal failure
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nppes
1 records
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