Integra Dermal Regeneration Template recallZ-2328-2008 · Integra LifeSciences Corp · initiated Jul 2, 2008
Terminated All recalls posted in September 2008
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
Product labeled with an expiration date on May 2010, while the actual expiration date should be April 2010.
FDA root cause category: Labeling mix-ups
What the company is doing
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.
Recall details
- Recall number
- Z-2328-2008
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jul 2, 2008
- Posted by the FDA
- Sep 20, 2008
- Recalling firm
- Integra LifeSciences Corp
- Quantity
- 10 units
- Product code
- MDD
- FDA submissions
- P900033
- Distribution
- Product was distributed to 5 hospitals in TN, CA, NY, IN and AL.
Product description
Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile; Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 USA
Code information (models, lots, serial numbers)
Catalog Number 38101, Lot Number 105BA0121823
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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