Z-1035-2009

Integra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021

Name: Z-1035-2009 Integra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021
Creator: Integra LifeSciences Corp
Published: 2009-01-16
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2009-01-16 / Terminated / root cause: packaging

FDA source

Integra LifeSciences Corp began a recall of Integra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021 on 2009-01-16. The reason FDA records is "Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1035-2009
Status: Terminated
Initiated: 2009-01-16
Posted: 2009-03-06
Terminated: 2009-06-25
Recalling firm: Integra LifeSciences Corporation
Product: Integra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021
Product code: MDD Device, Dermal Replacement
Reason for recall: Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained.
Root cause tag: packaging
FDA root cause: Pending
Action: Urgent: Product Recall Notification letters were sent on January 21, 1009 via Federal Express. The letter asked customers to immediately quarantine any stock on hand and contact their local Integra Sales Representative for further assistance and arrangement of product returns. The enclosed "Recall Acknowledgement and Return Form" indicating whether or not customers possess any of the affected product should also be completed and returned. Company is conducting recall to the hospital level. Questions should be directed to Judy O'Grady at 609-936-2317.
Quantity in commerce: 31 units
Distribution: Nationwide Distribution -- including states of FL, CA, GA, FL, CT, MT, IL, TX, WA, TN, NC, IN, AZ, MD, CO, MO, and TN.
Product codes and lots: Lot Numbers: 105BA0134826 and 105BB0134826. Lot Numbers: 105BY0134826 and 105BW0134826.

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)