# P950032: Apligraf (Graftskin)

- Pathway: PMA
- Applicant: Organogenesis, Inc.
- Decided: May 22, 1998 after 961 days
- Product code: MGR (Dressing, Wound And Burn, Interactive)
- Device class: 3
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Feb 21, 2011 · Not classified · Z-1747-2011: Product sterility may be compromised
- Jan 30, 2011 · Not classified · Z-1746-2011: Product sterility compromised
- Aug 2, 2010 · Not classified · Z-2589-2010: Product is contaminated with a yeast identified as Pseudozyma antarctica.
- Sep 27, 2009 · Not classified · Z-0181-2010: Unit contaminated with Staphylococcus epidermidis
- Dec 26, 2007 · Not classified · Z-0675-2008: Contamination: Apligraf units were reported to have contamination in the agarose nutrient medium of some units retained at Organogenesis. Preliminary tests show a gram negative rod (bacillus) organism
- Sep 29, 2006 · Not classified · Z-0068-2007: Product pH out of specification

Source page: https://510kreport.com/device/P950032
Methodology: https://510kreport.com/methodology