FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp: Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile; Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 USA
- Recall number
- Z-2328-2008
- Recalling firm
- Integra LifeSciences Corp
- 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
- Status
- Terminated
- Initiated
- 2008-07-02
- Posted
- 2008-09-20
- Terminated
- 2008-09-22
- Reason
- Product labeled with an expiration date on May 2010, while the actual expiration date should be April 2010.
- 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
- 10 units
- Distribution
- Product was distributed to 5 hospitals in TN, CA, NY, IN and AL.
- Lot, serial or model codes
- Catalog Number 38101, Lot Number 105BA0121823
- 510(k) numbers
- not on file
- PMA numbers
- ["P900033"]
- Product code
- MDD
- Firm FEI
- 1121308
- Firm city
- Plainsboro
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28