FDA Medical Device Recalls (openFDA)
Lifecore Biomedical, Inc.: TefGen is an implant material which is intended to be used as a temporary space-making barrier over bone or other tissue.
- Recall number
- Z-1073-04
- Recalling firm
- Lifecore Biomedical, Inc.
- Product
- TefGen is an implant material which is intended to be used as a temporary space-making barrier over bone or other tissue.
- Status
- Terminated
- Initiated
- 2004-06-03
- Posted
- 2004-07-20
- Terminated
- 2006-07-22
- Reason
- Packaged product labeled catalog #TFS30, lot number 002419 actually contained catalog #TFR60, lot number 002441and vice versa.
- Root cause
- Other
- Action
- Each facility was notified of the recall by letter on 06/03/2004.
- Quantity
- 200 of lot #002419 and 55 of lot #002441
- Distribution
- Throughout the U.S., Germany, France, Korea, Columbia, Chile and Korea
- Lot, serial or model codes
- catalog #TFS30 lot number 002419 and catalog #TFR60 lot number 002441
- 510(k) numbers
- ["K935137"]
- PMA numbers
- not on file
- Product code
- LYC
- Firm FEI
- 1000115753
- Firm city
- Chaska
- Firm state
- MN
- 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