TefGen is an implant material which is intended to be used as a temporary space-making barrier over bone or other tissue
FDA device recall Z-1073-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- Lifecore Biomedical, Inc.
- Reason for recall
- Packaged product labeled catalog #TFS30, lot number 002419 actually contained catalog #TFR60, lot number 002441and vice versa.
- Action taken
- Each facility was notified of the recall by letter on 06/03/2004.
- Root cause
- Other
- Status
- Terminated
- Product code
- LYC
- Quantity affected
- 200 of lot #002419 and 55 of lot #002441
- Distribution
- Throughout the U.S., Germany, France, Korea, Columbia, Chile and Korea
- Date initiated
- 2004-06-03
- Date posted
- 2004-07-20
- Date terminated
- 2006-07-22
- Location
- Chaska, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TEFGEN-FD (K935137) | American Custom Medical, Inc. | 1994-08-15 |