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U.S. Department of Health and Human Services

Class 3 Device Recall TefGenFD

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  Class 3 Device Recall TefGenFD see related information
Date Initiated by Firm June 03, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on July 22, 2006
Recall Number Z-1073-04
Recall Event ID 29382
510(K)Number K935137  
Product Classification Bone Grafting Material, Synthetic - Product Code LYC
Product TefGen is an implant material which is intended to be used as a temporary space-making barrier over bone or other tissue.
Code Information catalog #TFS30 lot number 002419 and catalog #TFR60 lot number 002441
Recalling Firm/
Manufacturer		 Lifecore Biomedical, Inc.
3515 Lyman Blvd
Chaska MN 55318
Manufacturer Reason
for Recall		 Packaged product labeled catalog #TFS30, lot number 002419 actually contained catalog #TFR60, lot number 002441and vice versa.
FDA Determined
Cause 2		 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LYC and Original Applicant = AMERICAN CUSTOM MEDICAL, INC.
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