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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile Disposable Kit

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  Class 2 Device Recall Sterile Disposable Kit see related information
Date Initiated by Firm October 13, 2013
Date Posted November 18, 2013
Recall Status1 Terminated 3 on December 10, 2013
Recall Number Z-0355-2014
Recall Event ID 66558
510(K)Number K123548  
Product Classification Computer assisted hair harvesting system - Product Code ONA
Product Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-25117, follicle Trap PRT 23999):


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-45547
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 2		 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 cnfigurations)
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 and Original Applicant = RESTORATION ROBOTICS, INC
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