FDA Medical Device Recalls (openFDA)
Integra LifeSciences Corp: Integra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021
- Recall number
- Z-1035-2009
- Recalling firm
- Integra LifeSciences Corp
- Product
- Integra Dermal Regeneration Template-TS Catalog number 32021 Catalog number 82021
- Status
- Terminated
- Initiated
- 2009-01-16
- Posted
- 2009-03-06
- Terminated
- 2009-06-25
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- Lot Numbers: 105BA0134826 and 105BB0134826. Lot Numbers: 105BY0134826 and 105BW0134826.
- 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