Class 2 Device Recall MaxTorque Cannulated Screw

• Date Initiated by Firm: April 07, 2009
• Date Posted: April 06, 2010
• Recall Status: Terminated on October 20, 2010
• Recall Number: Z-1250-2010
• Recall Event ID: 54540
• 510(K)Number: K060428
• Product Classification: screw, fixation, bone - Product Code HWC
• Product: MaxTorque Cannulated Screw Model # MSD-010-55-060S
• Code Information: Model # MSD-010-55-060S
• 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: A pinhead sized disc was found in the cannulation of a MSD-010-55-60S screw.
• FDA Determined Cause: Other
• Action: On April 7, 2009 the firm sent letters to their customers with detailed instructions on how to correct the problem. Pictures were included for clarification. For questions please contact either Jim Bragg via phone at 330-869-9562 ext 211 or Kristin Wolff at ext 209.
• Quantity in Commerce: 45 pieces
• Distribution: Product was delivered to: CA, CO, GA, NM, NY, OH, VA & 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 = HWC and Original Applicant = ORTHOHELIX SURGICAL DESIGNS, INC.