Z-1746-2011

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

Name: Z-1746-2011 Organogenesis Apligraf Interactive burn and wound dressing, supplied as a living, bi-layered skin substitute
Creator: Organogenesis, Inc.
Published: 2011-01-30
License: https://open.fda.gov/license/

Organogenesis, Inc. / initiated 2011-01-30 / Terminated / root cause: manufacturing process

FDA source

Organogenesis, Inc. began a recall of Organogenesis Apligraf Interactive burn and wound dressing, supplied as a living, bi-layered skin substitute on 2011-01-30. The reason FDA records is "Product sterility compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1746-2011
Status: Terminated
Initiated: 2011-01-30
Posted: 2011-03-23
Terminated: 2011-07-28
Recalling firm: Organogenesis, Inc.
Product: Organogenesis Apligraf Interactive burn and wound dressing, supplied as a living, bi-layered skin substitute
Product code: MGR Dressing, Wound And Burn, Interactive
Reason for recall: Product sterility compromised
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: Organogenesis notified accounts on Sunday, January 30, 2011, via fax and phone. The Company will collect written confirmation from the affected customers that they have been notified of the recall. Sales representatives for the affected customers have been directed to visit the customers as soon as possible Monday morning to assist in the recall and prevent additional applications of the product. Apligraf Medical Affairs personnel will provide clinical support to treating physicians, and update them as new information on microbial contamination and antibiotic susceptibility becomes available. Units not applied have been requested to be returned to Organogenesis
Quantity in commerce: 50 units
Distribution: nationwide.
Product codes and lots: Lot Number GS1012.28.05.2A Unit Numbers: 2, 5, 6, 7,8, 9,10, 11, 12, 13, 14, 15,16, 17,18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 29, 31, 32, 34, 36, 37, 38, 39, 40, 41, 42,43, 44, 45,46, 50,51, 52, 53, 55, 56, 69 ,135, 200

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)