Class 2 Device Recall Bone Grafting material

• Date Initiated by Firm: February 17, 2005
• Date Posted: March 09, 2005
• Recall Status: Terminated 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
• FEI Number: 1721411
• 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: 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