Class 2 Device Recall Straumann Bone Level Tapered Implant

• Date Initiated by Firm: September 19, 2014
• Date Posted: October 23, 2014
• Recall Status: Terminated on March 13, 2015
• Recall Number: Z-0117-2015
• Recall Event ID: 69379
• 510(K)Number: K140878
• Product Classification: Implant, endosseous, root-form - Product Code DZE
• Product: Straumann Bone Level Tapered Implant 04.1 mm RC, SLActive 8mm, Roxolid, Loxim Article Number: 021 .5308 Dental implants are intended for surgical placement in maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. Dental implants are for single-stage or two-stage surgery.
• Code Information: Lot number: GY030 Exp. 2019-04
• Recalling Firm/ Manufacturer: Straumann USA, LLC; 60 Minuteman Rd; Andover MA 01810-1008
• For Additional Information Contact: Same; 800-448-8168
• Manufacturer Reason for Recall: Assembled with Narrow Connect (NC) transfer piece instead of Regular Connect (RC)
• FDA Determined Cause: Packaging process control
• Action: Strauman notified consignees of this Field Corrective Action by letter dated September 19, 2014 and delivered via hand by Straumann Representative. Accounts are requested to return inventory. Contact (978) 747-2514 for assistance.
• Quantity in Commerce: 6 units
• Distribution: US Distribution in states of: FL and MA.
• 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