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U.S. Department of Health and Human Services

Class 2 Device Recall Bone Grafting material

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  Class 2 Device Recall Bone Grafting material see related information
Date Initiated by Firm February 17, 2005
Date Posted March 09, 2005
Recall Status1 Terminated 3 on April 22, 2005
Recall Number Z-0579-05
Recall Event ID 31192
PMA Number P990033 
Product Classification Bone Grafting Material, Dental, With Biologic Component - Product Code NPZ
Product PepGen P-15 Putty (0.5cc)
Code Information Article Number: 99U200-005 Lot Number: 04P1017A
Recalling Firm/
Manufacturer		 Dentsply Friadent Ceramed
12860 W Cedar Dr Ste 110
Lakewood CO 80228-1965
Manufacturer Reason
for Recall		 PepGen P-15 Putty kit was labeled with the incorrect expiration date.
FDA Determined
Cause 2		 Other
Action Customers were sent notification letters dated 02/17/05.
Quantity in Commerce 250 kits
Distribution Domestic distribution: Nationwide. Foreign distribution: Canada, British Columbia. No military or VA facilites.
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.
PMA Database PMAs with Product Code = NPZ and Original Applicant = CERAMED CORP.
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