Z-0904-03

Dermagraft, Human Fibroblast -Derived Dermal Substitute, 2 in. by 3 in

Name: Z-0904-03 Dermagraft, Human Fibroblast -Derived Dermal Substitute, 2 in. by 3 in
Creator: Smith and Nephew Wound Management (La Jolla)
Published: 2003-05-02
License: https://open.fda.gov/license/

Organogenesis, Inc. / initiated 2003-05-02 / Terminated

FDA source

Smith and Nephew Wound Management (La Jolla) began a recall of Dermagraft, Human Fibroblast -Derived Dermal Substitute, 2 in. by 3 in on 2003-05-02. The reason FDA records is "Did not meet finished device specifications for the DNA criteria". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0904-03
Status: Terminated
Initiated: 2003-05-02
Posted: 2003-06-04
Terminated: 2003-11-03
Recalling firm: Organogenesis, Inc.
Product: Dermagraft, Human Fibroblast -Derived Dermal Substitute, 2 in. by 3 in..
Product code: MGR Dressing, Wound And Burn, Interactive
Reason for recall: Did not meet finished device specifications for the DNA criteria.
FDA root cause: Other
Action: Recall was by telephone on or about May 2, 2003 and by letter on May 7, 2003. Product is to be returned.
Quantity in commerce: 22
Distribution: To hospitals nationwide.
Product codes and lots: Lot 116098

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)