Recall Z-1073-04 ยท LYC Bone Grafting Material, Synthetic
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.
| Date | Jul 20, 2004 (initiated Jun 3, 2004) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K935137 | TEFGEN-FD American Custom Medical, Inc., Aug 15, 1994 |