Z-1073-04

TefGen is an implant material which is intended to be used as a temporary space-making barrier over bone or...

Name: Z-1073-04 TefGen is an implant material which is intended to be used as a temporary space-making barrier over bone or...
Creator: Lifecore Biomedical, Inc.
Published: 2004-06-03
License: https://open.fda.gov/license/

Lifecore Biomedical LLC / initiated 2004-06-03 / Terminated / root cause: labeling and UDI

FDA source

Lifecore Biomedical, Inc. began a recall of TefGen is an implant material which is intended to be used as a temporary space-making barrier over bone or other tissue on 2004-06-03. The reason FDA records is "Packaged product labeled catalog #TFS30, lot number 002419 actually contained catalog #TFR60, lot number 002441and vice versa". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1073-04
Status: Terminated
Initiated: 2004-06-03
Posted: 2004-07-20
Terminated: 2006-07-22
Recalling firm: Lifecore Biomedical LLC
Product: TefGen is an implant material which is intended to be used as a temporary space-making barrier over bone or other tissue.
Product code: LYC Bone Grafting Material, Synthetic
Reason for recall: Packaged product labeled catalog #TFS30, lot number 002419 actually contained catalog #TFR60, lot number 002441and vice versa.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Each facility was notified of the recall by letter on 06/03/2004.
Quantity in commerce: 200 of lot #002419 and 55 of lot #002441
Distribution: Throughout the U.S., Germany, France, Korea, Columbia, Chile and Korea
Product codes and lots: catalog #TFS30 lot number 002419 and catalog #TFR60 lot number 002441

Product code LYC

K935137Class IITefgen-FdAmerican Custom Medical, Inc. / cleared 1994-08-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)