FDA Medical Device Recalls (openFDA)
Organogenesis, Inc.: Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living, bilayered skin substitute
- Recall number
- Z-1747-2011
- Recalling firm
- Organogenesis, Inc.
- Product
- Organogenesis Apligraf - Interactive burn and wound dressing, supplied as a living, bilayered skin substitute
- Status
- Terminated
- Initiated
- 2011-02-21
- Posted
- 2011-03-23
- Terminated
- 2011-07-28
- Reason
- Product sterility may be compromised
- Root cause
- Packaging process control
- Action
- Organogenesis contacted the accounts by telephone and fax on 2/24/11 to advise of the contamination and identification fo the organism for appropriate patient follow-up.
- Quantity
- 7 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Packaging Lot:: GS1101-13-.02.2A Unit Numbers: 3, 13, 25, 28, 46, 76, 128 Exp. Date 23 Feb 2011
- 510(k) numbers
- not on file
- PMA numbers
- ["P950032"]
- Product code
- MGR
- Firm FEI
- 1000148471
- Firm city
- Canton
- Firm state
- MA
- 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