Integra Dermal Regeneration Template-TS recallZ-1035-2009 · Integra LifeSciences Corp · initiated Jan 16, 2009
Terminated All recalls posted in March 2009
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Integra LifeSciences Corp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Pending
What the company is doing
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.
Recall details
- Recall number
- Z-1035-2009
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jan 16, 2009
- Posted by the FDA
- Mar 6, 2009
- Recalling firm
- Integra LifeSciences Corp
- Quantity
- 31 units
- Product code
- MDD
- FDA submissions
- P900033
- 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 description
Integra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021
Code information (models, lots, serial numbers)
Lot Numbers: 105BA0134826 and 105BB0134826. Lot Numbers: 105BY0134826 and 105BW0134826.
Other devices under the same FDA submission
1 device cleared under P900033 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Omnigraft™ DFU25251Integra Lifesciences Corporation · DEVICE, DERMAL REPLACEMENT1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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