Class 3 Device Recall Straumann

• Date Initiated by Firm: March 30, 2006
• Date Posted: May 04, 2006
• Recall Status: Terminated on June 14, 2006
• Recall Number: Z-0840-06
• Recall Event ID: 35220
• 510(K)Number: K960634
• Product Classification: Implant, Endosseous, Root-Form - Product Code DZE
• Product: Straumann Narrow Neck (NN) Healing Cap with integral occlusal screw Height: 3.4mm Ref: 048.043
• Code Information: Lot Number: A3667
• Recalling Firm/ Manufacturer: Straumann Manufacturing Inc.; 60 Minuteman Rd; Andover MA 01810-1008
• For Additional Information Contact: Bernard M.McDonald; 978-747-2514
• Manufacturer Reason for Recall: The occlusal screw is inserted in the bottom of the healing cap body rather than correctly through the top
• FDA Determined Cause: Other
• Action: Straumann USA notified accounts by letter dated 3/30/06 via Federal Express. Accounts are requested to return stock.
• Quantity in Commerce: 103 units
• Distribution: Nationwide. CA, CO, CT, IA, IL, IN, FL, GA, MA , MD, MS, NC, NY, OH, OK, PA, TX, WA
• 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 = DZE