Class 3 Device Recall Straumann

• Date Initiated by Firm: November 11, 2004
• Date Posted: December 09, 2004
• Recall Status: Terminated on February 17, 2005
• Recall Number: Z-0300-05
• Recall Event ID: 30482
• Product Classification: Accessories, Implant, Dental, Endosseous - Product Code NDP
• Product: Straumann Dental Implant System, SP Profile Drill, Short, 04.2 mm, RN, L25.0 mm, Stainless steel Ref. Number: 044.084
• Code Information: Lot Numbers: 1300 and 1301
• FEI Number: 1000121052
• Recalling Firm/ Manufacturer: The Straumann Company; 1601 Trapelo Road; Waltham MA 02451-7333
• For Additional Information Contact: Bernard M. McDonald; 781-890-0001 Ext. 9831
• Manufacturer Reason for Recall: Outside label incorrectly identifes drill as Regular Neck (RN) instead of Wide Neck (WN)
• FDA Determined Cause: Other
• Action: Straumann USA notified users by letter dated 11/11/04 via overnight mail advising users of the label error.
• Quantity in Commerce: 85 units
• Distribution: Nationwide
• 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.