FDA Medical Device Recalls (openFDA)
Smith and Nephew Wound Management (La Jolla): Dermagraft, Human Fibroblast -Derived Dermal Substitute, 2 in. by 3 in..
- Recall number
- Z-0904-03
- Recalling firm
- Smith and Nephew Wound Management (La Jolla)
- Product
- Dermagraft, Human Fibroblast -Derived Dermal Substitute, 2 in. by 3 in..
- Status
- Terminated
- Initiated
- 2003-05-02
- Posted
- 2003-06-04
- Terminated
- 2003-11-03
- Reason
- Did not meet finished device specifications for the DNA criteria.
- Root cause
- Other
- Action
- Recall was by telephone on or about May 2, 2003 and by letter on May 7, 2003. Product is to be returned.
- Quantity
- 22
- Distribution
- To hospitals nationwide.
- Lot, serial or model codes
- Lot 116098
- 510(k) numbers
- not on file
- PMA numbers
- P000036
- Product code
- MGR
- Firm FEI
- 1000148471
- Firm city
- San Diego
- Firm state
- CA
- 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