Class 2 Device Recall Mini Max Torque Drill Bit & Countersink

• Date Initiated by Firm: September 03, 2009
• Date Posted: April 22, 2010
• Recall Status: Terminated on February 28, 2012
• Recall Number: Z-1430-2010
• Recall Event ID: 54541
• 510(K)Number: K082574
• Product Classification: Drill Bit - Product Code HTW
• Product: Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-38. Used to drill or cut bone prior to implantation of screws
• Code Information: Lot NG808, Lot NG861, & Lot 1048031.
• FEI Number: 3000718467
• Recalling Firm/ Manufacturer: Orthohelix Surgical Designs Inc; 1065 Medina Rd., Suite 500; Medina OH 44256
• For Additional Information Contact: 330-869-9582
• Manufacturer Reason for Recall: The epoxy is flaking off the drill bits and countersinks.
• FDA Determined Cause: Nonconforming Material/Component
• Action: On 9/3/2009 the firm sent letters to their customers requesting return of all recalled product in stock and for those products to be replaced with the ones listed in the letter. Questions should be directed to 330-869-0625.
• Quantity in Commerce: 74 pieces
• Distribution: Nationwide Distribution -- CO, OH, PA, SD, TX & VA.
• 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 = HTW