Class 2 Device Recall Twist Drill with J Notch

• Date Initiated by Firm: November 06, 2009
• Date Posted: December 16, 2009
• Recall Status: Terminated on March 02, 2010
• Recall Number: Z-0538-2010
• Recall Event ID: 53943
• 510(K)Number: K062842
• Product Classification: Drills, burrs, trephines & accessories (simple, powered) - Product Code HBE
• Product: Biomet 1.1 X 50MM, 3.5MM STOP STAINLESS STEEL, 1.5MM SYSTEM TWIST DRILL WITH J NOTCH, REF 01-7141. DISTRIBUTED BY: BIOMET MICROFIXATION 1520 TRADEPORT DRIVE JACKSONVILLE, FL 32218 USA. A single use twist drill intended for drilling holes in large and small bone during orthopedic, spinal, neurosurgical, medial sternotomy, and oral and maxillofacial procedures.
• Code Information: Lots: 535933, 536306 and 537407.
• FEI Number: 1032347
• Recalling Firm/ Manufacturer: Biomet Microfixation, Inc.; 1520 Tradeport Dr; Jacksonville FL 32218-2480
• For Additional Information Contact: Laura Sabo; 904-741-4400
• Manufacturer Reason for Recall: The Twist Drill 1.1x50mm, 3.5mm stop, with J notch Lots #'s 537407, 536306, and 535933 which were packaged and shipped without the instructions for use (IFU).
• FDA Determined Cause: Process change control
• Action: Consignees were notified of the recall by a combination of telephone calls, letters, and emails during the week of November 16, 2009. Customers were instructed to complete the Inventory Reconciliation Sheet and fax (1-904-741-9425) to the firm. Customers who further distributed the affected product was instructed to notify recipients of the recall. Direct questions about the recall to Biomet Microfixation, Inc. by calling 1-800-874-7711 or 1-904-741-4400, extension 468, Monday through Friday, 8 a.m. to 4 p.m. Eastern Standard Time.
• Quantity in Commerce: 283 pieces
• Distribution: Worldwide Distribution -- United States (including Puerto Rico), Australia, Brazil, Canada, Chile, Europe, France, Germany, Greece, Japan, Lebanon, Spain, and the United Arab Emirates.
• 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 = HBE