Class 2 Device Recall Straumann Palatal Implant

• Date Initiated by Firm: September 28, 2007
• Date Posted: December 04, 2007
• Recall Status: Terminated on April 16, 2010
• Recall Number: Z-0277-2008
• Recall Event ID: 45420
• 510(K)Number: K060062
• Product Classification: Endosseous Orthodontic Implant - Product Code OAT
• Product: Straumann Palatal Implant , 04.1 L 4.2 mm,; Article Number: 042.335S, Straumann USA., LLC, Andover, Massachusetts, 01810-1008
• Code Information: Lot Numbers: 1001, F3776, F4662, F6563, E7083
• 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: Sticking Transfer Piece: The Transfer Piece which accompanies the Palatal Implant may get stuck during implant requiring removal by using mechanical force.
• FDA Determined Cause: Device Design
• Action: Straumann USA, LLC sent Urgent Device Recall letters, via FedFx on 9/28/07, requesting the return of all Straumann Palatal Implant, articles 042.335 with lot numbers 1001, FE3776, F4662, F6563, E7083, and article 042.336S lot number 1001.
• Quantity in Commerce: 58 units
• Distribution: Nationwide Distribution - USA including states of AZ, CA, CO, ID, IL, IN, GA, KY, NH , MA, MD, MI, NM, PA, TX, UT, VA, and 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 = OAT and Original Applicant = INSTITUT STRAUMANN AG