Class 2 Device Recall Straumann

• Date Initiated by Firm: June 06, 2005
• Date Posted: July 07, 2005
• Recall Status: Terminated on November 03, 2005
• Recall Number: Z-0975-05
• Recall Event ID: 32354
• 510(K)Number: K020096
• Product Classification: Implant, Endosseous, Root-Form - Product Code DZE
• Product: RN synOcta Meso Abutment, crown margin 8.0mm, Ti Article: 048.560
• Code Information: Lot Number: 1007
• Recalling Firm/ Manufacturer: Straumann Manufacturing Inc; 60 Minuteman Rd; Andover MA 01810
• For Additional Information Contact: Linda Jalbert; 978-742-2500 Ext. 2506
• Manufacturer Reason for Recall: Basal screw is too short to adequately hold the dental abutment in the implant
• FDA Determined Cause: Other
• Action: Straumann USA initiated the recall by letter dated 6/6/05. Users are requested to return devices and to examine patients with the implanted device.
• Quantity in Commerce: 23
• Distribution: AZ, CA, DE, FL, NY, OH, OK, TX
• 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