Class 2 Device Recall TIGER Canulated Screw System

• Date Initiated by Firm: April 14, 2009
• Date Posted: April 26, 2010
• Recall Status: Terminated on May 03, 2010
• Recall Number: Z-1438-2010
• Recall Event ID: 55180
• 510(K)Number: K081510
• Product Classification: screw, fixation, bone - Product Code HWC
• Product: 2.0/2.4 Cannulated Screw Driver Bit, part #210-24-003
• Code Information: Lot #0924081
• Recalling Firm/ Manufacturer: Trilliant Surgical LTD; 448 W 19th St Ste 366; Houston TX 77008-3914
• For Additional Information Contact: 800-495-2919
• Manufacturer Reason for Recall: Firm received several complaints of field failures, e.g., "broke during surgery" and the firm initiated a design change. A communication to sales staff 04/14/2009 instructed them to recover and reconcile these products from user physicians.
• FDA Determined Cause: Other
• Action: Firm notified sales force by e-mail on 4/14/2009 of the need to recover and reconcile this product . Additional documentation is not available from the firm. Questions may be directed directly to the firm at 800-495-2919.
• Quantity in Commerce: 32 units
• Distribution: WI, TX, MO, NM, MN, OK, MA, CA, GA, ND, NE, IA, NY, LA, and MD
• 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 = HWC and Original Applicant = TRILLIANT SURGICAL LTD