Class 3 Device Recall Straumann Handpiece Driver

• Date Initiated by Firm: May 28, 2008
• Date Posted: September 16, 2008
• Recall Status: Terminated on November 06, 2009
• Recall Number: Z-1876-2008
• Recall Event ID: 48610
• Product Classification: Endosseous dental implant - Product Code DZE
• Product: Straumann Handpiece Driver for RN Solid Abutment 6 L 26.0mm,Stainless Steel -- Reference Number: 80426. Product is intended as radiographic guides and surgical templates for the initial placement of the 2.2 mm pilot drill used in the site preparation for the placement of Straumann dental implants.
• Code Information: Lot Number: C4724
• Recalling Firm/ Manufacturer: Straumann Manufacturing Inc.; 60 Minuteman Rd; Andover MA 01810-1008
• For Additional Information Contact: 800-448-8168
• Manufacturer Reason for Recall: Handpiece driver is out of specification and will not function with the dental solid abutment. Possible risks involved include: inconvenience to patient and the need to reschedule surgery or proceed without the device.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On May 28, 2008, Straumann issued an Urgent Device Recall and a Recall Acknowledgement Form to its consignees via Fed Ex. Accounts are requested to return product and a replacement or credit will issue. If you have any questions contact Bernie McDonald at (978) 747-2514.
• Quantity in Commerce: 129 units
• Distribution: Class III Recall - Nationwide Distribution.
• 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.