Dressing, Wound And Burn, Interactive
FDA product code MGR · Class III (high risk) · General, Plastic Surgery
0510(k) clearances
5PMA approvals
6recalls
PMA approvals
- P000036 Dermagraft · Shire Regenerative Medicine · 09/28/2001
- P010016 Orcel Bilayered Cellular Matrix · Forticell Bioscience · 08/31/2001
- P950032 Apligraf (Graftskin) · Organogenesis, Inc. · 05/22/1998
- P960007 Transcyte Human Fibroblast-Derived Temporary Skin Substitute · Shire Regenerative Medicine · 03/18/1997
- P900033 Integra Dermal Regeneration Template · Integra Lifesciences Corp. · 03/01/1996
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1747-2011 | Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living…Product sterility may be compromised | Organogenesis, Inc. | 02/21/2011Terminated |
| Z-1746-2011 | Organogenesis Apligraf Interactive burn and wound dressing, supplied as a living…Product sterility compromised | Organogenesis, Inc. | 01/30/2011Terminated |
| Z-2589-2010 | Apligraf is supplied as a living, bi-layered skin substitute. Article Number: GS100…Product is contaminated with a yeast identified as Pseudozyma antarctica. | Organogenesis, Inc. | 08/02/2010Terminated |
| Z-0181-2010 | Organogenesis, Inc., Apligraf (draftskin) packaging, Canton, MA 02021. Indicated for use…Unit contaminated with Staphylococcus epidermidis | Organogenesis, Inc. | 09/27/2009Terminated |
| Z-0675-2008 | Organogenesis Apligraf, interactive wound and burn dressing, Organogenesis, Inc.…Contamination: Apligraf units were reported to have contamination in the agarose nutrient medium of some… | Organogenesis, Inc. | 12/26/2007Terminated |
| Z-0068-2007 | Apligraf (Graftskin)Product pH out of specification | Organogenesis, Inc. | 09/29/2006Terminated |