Z-2589-2010

Apligraf is supplied as a living, bi-layered skin substitute. Article Number: GS100 Indicated for use with...

Name: Z-2589-2010 Apligraf is supplied as a living, bi-layered skin substitute. Article Number: GS100 Indicated for use with...
Creator: Organogenesis, Inc.
Published: 2010-08-02
License: https://open.fda.gov/license/

Organogenesis, Inc. / initiated 2010-08-02 / Terminated / root cause: manufacturing process

FDA source

Organogenesis, Inc. began a recall of Apligraf is supplied as a living, bi-layered skin substitute. Article Number: GS100 Indicated for use with standard therapeutic compression for the treatment... on 2010-08-02. The reason FDA records is "Product is contaminated with a yeast identified as Pseudozyma antarctica". 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-2589-2010
Status: Terminated
Initiated: 2010-08-02
Posted: 2010-09-28
Terminated: 2011-03-10
Recalling firm: Organogenesis, Inc.
Product: Apligraf is supplied as a living, bi-layered skin substitute. Article Number: GS100 Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1 month duration and which have not adequately responded to conventional ulcer therapy.
Product code: MGR Dressing, Wound And Burn, Interactive
Reason for recall: Product is contaminated with a yeast identified as Pseudozyma antarctica.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Organogenesis notified accounts by telephone, e-mail or fax on 8/2/010 to remove from use and return recalled units. If unit was applied to patient then monitor for adverse events. The Notification Letter dated August 6, 2010, described the issue and provided instructions for customers. Customers are to place the affected unit on hold for its return to the firm. The firm will contact customers to make arrangements for its return. Replacements have already been sent. If the affected unit has already been applied, the patients should be monitored closely for any potential adverse events. An Organogenesis Medical Affairs rep will be in contact regarding patient follow up. Customers are to complete the attached form and fax it back to the number provided. Questions should be directed to the Medical Information Center at 1-888-432-5232.
Quantity in commerce: 32 units
Distribution: Nationwide Distribution -- AL, AZ, CA, CO, IL NC, PA, TN, and VA.
Product codes and lots: Lot # GS1007.06.03.1A Unit numbers: 146-, 148, 149, 150, 151, 152, 154, 155, 157, 158, 159, 160, 162, 163, 172, 173, 174, 175, 176, 177, 178, 180, 181, 182, 184, 185, 186, 187, 188, 189, and 190.

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)