Material, Dressing, Surgical, Polylactic Acid
FDA product code LPG · Class III (high risk) · Dental
0510(k) clearances
2PMA approvals
7recalls
PMA approvals
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1297-2013 Class II | Ora Plug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | Integra LifeSciences Corporation | 03/28/2013Terminated |
| Z-1296-2013 Class II | OraTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | Integra LifeSciences Corporation | 03/28/2013Terminated |
| Z-1295-2013 Class II | HeliPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | Integra LifeSciences Corporation | 03/28/2013Terminated |
| Z-1294-2013 Class II | HeliTape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | Integra LifeSciences Corporation | 03/28/2013Terminated |
| Z-1293-2013 Class II | CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | Integra LifeSciences Corporation | 03/28/2013Terminated |
| Z-1292-2013 Class II | CollaCote Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | Integra LifeSciences Corporation | 03/28/2013Terminated |
| Z-1291-2013 Class II | Colla Tape Absorbable Collagen Wound Dressing for Dental Surgery The Absorbable Collagen…Due to the process deviation, product lots in question may have been released with higher levels of pyrogens… | Integra LifeSciences Corporation | 03/28/2013Terminated |