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Terminated

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

FDA Recall Z-1073-04 · Posted 2004-07-20

Recalling FirmLifecore Biomedical, Inc.
Recall StatusTerminated
Product CodeLYC
Date Initiated2004-06-03
Date Terminated2006-07-22
Product Quantity200 of lot #002419 and 55 of lot #002441

Reason for Recall

Packaged product labeled catalog #TFS30, lot number 002419 actually contained catalog #TFR60, lot number 002441and vice versa.

Firm Action

Each facility was notified of the recall by letter on 06/03/2004.

Root Cause

Other

Distribution Pattern

Throughout the U.S., Germany, France, Korea, Columbia, Chile and Korea

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K935137TEFGEN-FDAmerican Custom Medical, Inc. · 1994-08-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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