Class 2 Device Recall ARTUS system Disposable Kit

• Date Initiated by Firm: October 13, 2013
• Date Posted: November 18, 2013
• Recall Status: Terminated on December 10, 2013
• Recall Number: Z-0356-2014
• Recall Event ID: 66558
• 510(K)Number: K123548
• Product Classification: Computer assisted hair harvesting system - Product Code ONA
• Product: ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; dissection Punch 4.0mm FP 23304; Saline Nose Cone FP-45387; Follicle Trap FP 23306; Non-Sterile Disposable kit FP 23267 and Molded Parts, Reusable Kit FP 45538 Rx): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions.
• Code Information: Model number FP-45399
• Recalling Firm/ Manufacturer: Restoration Robotics; 128 Bayview Drive; San Jose CA 95134
• For Additional Information Contact: Jim Talbot; 408-883-6760
• Manufacturer Reason for Recall: Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine.
• FDA Determined Cause: Process control
• Action: Restoration Robotics sent an Urgent Recall letters dated October 13, 2013 to all distributors via first class mail. Direct accounts were notified by phone as well as fax. Customers were informed of the affected product, problem and actions to be taken. Replacement products are being distributed to each site and will be delivered to each customer. For questions call 408-883-6760
• Quantity in Commerce: 515 US, 315 International (all Packaging configurations.
• Distribution: Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.
• 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 = ONA