Z-2328-2008

Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile; Integra LifeSciences Corporation...

Name: Z-2328-2008 Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile; Integra LifeSciences Corporation...
Creator: Integra LifeSciences Corp
Published: 2008-07-02
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2008-07-02 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corp began a recall of Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile; Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 USA on 2008-07-02. The reason FDA records is "Product labeled with an expiration date on May 2010, while the actual expiration date should be April 2010". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2328-2008
Status: Terminated
Initiated: 2008-07-02
Posted: 2008-09-20
Terminated: 2008-09-22
Recalling firm: Integra LifeSciences Corporation
Product: Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile; Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 USA
Product code: MDD Device, Dermal Replacement
Reason for recall: Product labeled with an expiration date on May 2010, while the actual expiration date should be April 2010.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: The firm issued a letter titled URGENT-RECALL NOTICE to Integra Sales Reps on July 2, 2008. Contact Integra at 609-799-3297 if you have questions.
Quantity in commerce: 10 units
Distribution: Product was distributed to 5 hospitals in TN, CA, NY, IN and AL.
Product codes and lots: Catalog Number 38101, Lot Number 105BA0121823

Product code MDD

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)