Z-1747-2011

Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living, bilayered skin substitute

Name: Z-1747-2011 Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living, bilayered skin substitute
Creator: Organogenesis, Inc.
Published: 2011-02-21
License: https://open.fda.gov/license/

Organogenesis, Inc. / initiated 2011-02-21 / Terminated / root cause: packaging

FDA source

Organogenesis, Inc. began a recall of Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living, bilayered skin substitute on 2011-02-21. The reason FDA records is "Product sterility may be compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1747-2011
Status: Terminated
Initiated: 2011-02-21
Posted: 2011-03-23
Terminated: 2011-07-28
Recalling firm: Organogenesis, Inc.
Product: Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living, bilayered skin substitute
Product code: MGR Dressing, Wound And Burn, Interactive
Reason for recall: Product sterility may be compromised
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Organogenesis contacted the accounts by telephone and fax on 2/24/11 to advise of the contamination and identification fo the organism for appropriate patient follow-up.
Quantity in commerce: 7 units
Distribution: Nationwide.
Product codes and lots: Packaging Lot:: GS1101-13-.02.2A Unit Numbers: 3, 13, 25, 28, 46, 76, 128 Exp. Date 23 Feb 2011

Product code MGR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)