FDA Medical Device Recalls (openFDA)
Organogenesis, Inc.: Apligraf (Graftskin)
- Recall number
- Z-0068-2007
- Recalling firm
- Organogenesis, Inc.
- Product
- Apligraf (Graftskin)
- Status
- Terminated
- Initiated
- 2006-09-29
- Posted
- 2006-10-24
- Terminated
- 2007-03-12
- Reason
- Product pH out of specification
- Root cause
- Other
- Action
- Organogenesis notified customers by fax on 9/29/06 through 10/2/06. Follow-Up telephone calls are being made. Users are requested to examine units for pH and return if product is out of spec., or verify unit was in spec for pH at time of use.
- Quantity
- 58
- Distribution
- Nationwide
- Lot, serial or model codes
- LOT: GS0609.05.01.2A Unit Numbers: 7, 8, 14, 15, 16, 18, 19, 25, 26, 29, 32, 34, 36, 40, 44, 46, 49, 52, 53, 54, 56, 58, 59, 60, 61, 63, 66, 68, 69, 70, 82 , 88, 91, 93, 94, 119, 120, 122, 126, 129, 130, 139, 142, 143, 144, 145 LOT:GS0609.05.02.1A Unit Numbers: 197, 198
- 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