Class 3 Device Recall Straumann NC Closure Screw

• Date Initiated by Firm: January 10, 2008
• Date Posted: April 30, 2008
• Recall Status: Terminated on November 06, 2009
• Recall Number: Z-1037-2008
• Recall Event ID: 46358
• 510(K)Number: K071585
• Product Classification: Precision attachment - Product Code EGG
• Product: Straumann NC Closure Screw, Titanium, Precision attachment, Article Number: 024.2105.04, Straumann, Andover, MA 01810
• Code Information: Lot Number: G8677
• Recalling Firm/ Manufacturer: Straumann Usa, Llc; 60 Minuteman Rd; Andover MA 01810-1008
• Manufacturer Reason for Recall: Mislabeled package: Narrow Connection (NC) Closure Screws contain closure screws for the regular connection (RC) bone level implant. The RC closures screw is larger (3.5mm diameter) and therefore, will not fit into the NC implant (3.0mm diameter) narrow connection.
• FDA Determined Cause: Mixed-up of materials/components
• Action: Consignees were notified by telephone on 1/10/08 followed by an Urgent Device Recall letter on January 10, 2008. The letter instructs users to return any affected product to the firm along with a recall acknowledgement form. For additional information, contact 978-747-2514.
• Quantity in Commerce: 26 units
• Distribution: Nationwide Distribution including states of CA, DE, FL, IL, ME, NY, OH, OR, and 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 = EGG