Z-0068-2007

Apligraf (Graftskin)

Name: Z-0068-2007 Apligraf (Graftskin)
Creator: Organogenesis, Inc.
Published: 2006-09-29
License: https://open.fda.gov/license/

Organogenesis, Inc. / initiated 2006-09-29 / Terminated

FDA source

Organogenesis, Inc. began a recall of Apligraf (Graftskin) on 2006-09-29. The reason FDA records is "Product pH out of specification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0068-2007
Status: Terminated
Initiated: 2006-09-29
Posted: 2006-10-24
Terminated: 2007-03-12
Recalling firm: Organogenesis, Inc.
Product: Apligraf (Graftskin)
Product code: MGR Dressing, Wound And Burn, Interactive
Reason for recall: Product pH out of specification
FDA root cause: Other
Action: Organogenesis notified customers by fax on 9/29/06 through 10/2/06. Follow-Up telephone calls are being made. Users are requested to examine units for pH and return if product is out of spec., or verify unit was in spec for pH at time of use.
Quantity in commerce: 58
Distribution: Nationwide
Product codes and lots: LOT: GS0609.05.01.2A Unit Numbers: 7, 8, 14, 15, 16, 18, 19, 25, 26, 29, 32, 34, 36, 40, 44, 46, 49, 52, 53, 54, 56, 58, 59, 60, 61, 63, 66, 68, 69, 70, 82 , 88, 91, 93, 94, 119, 120, 122, 126, 129, 130, 139, 142, 143, 144, 145 LOT:GS0609.05.02.1A Unit Numbers: 197, 198

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)