Class 2 Device Recall TransFx External Fixation System Drill Bit

• Date Initiated by Firm: May 01, 2009
• Date Posted: June 30, 2009
• Recall Status: Terminated on November 03, 2010
• Recall Number: Z-1534-2009
• Recall Event ID: 51924
• 510(K)Number: K003205 K984357 K990848 K991723
• Product Classification: Multiple Component Metallic Bone Fixation Appliance - Product Code LXT
• Product: TransFx External Fixation System Drill Bit, Quick Connect, 3.0 mm diameter, 180 mm length, nonsterile, Zimmer, Warsaw, IN; REF 4450-58. TransFx drill bits can be found in the following kits: TransFx Intermediate External Fixation System, REF 4450-05-10; TransFx Large External Fixation System, REF 4450-010-10 and TransFx Small External Fixation System, REF 4450-00050-15. For use in pre-drilling bone to accept a fixation pin, which are part of the external fixation structure that the surgeon assembles intra-operatively to stabilize bone fractures from the extremities.
• Code Information: Lots 53007600, 53024800, 56454669, 70185700, 70221300, 70227300, 70249300, 70249400, 70250100 and 70254900.
• Recalling Firm/ Manufacturer: Zimmer Inc.; 345 E Main St; Warsaw IN 46580-2746
• For Additional Information Contact: 800-613-6131
• Manufacturer Reason for Recall: Drill tip is out of specifications, reducing the efficiency of drilling action, requiring more force and potentially heating the bone surface during operation.
• FDA Determined Cause: Process control
• Action: Distributors and consignees were notified by an Urgent: Device Recall letter dated 5/1/09. Consignees were advised to stop using the device and quarantine it immediately. Distributors were instructed to carry out a physical count of all affected product and record the data on the Inventory Return Certification Form; fax a copy of the completed form to Zimmer, Inc.; and return recalled product along with the Inventory Return Certification Form to the firm.
• Quantity in Commerce: 707
• Distribution: Worldwide Distribution -- USA, Australia, Canada, El Salvador, England, Germany, Latin America, and Singapore.
• 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 = LXT