Events

Recall of Sterile Disposable Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Restoration Robotics.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    66558
  • Event Risk Class
    Class 2
  • Event Number
    Z-0355-2014
  • Event Initiated Date
    2013-10-13
  • Event Date Posted
    2013-11-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-12-10
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122605
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Computer assisted hair harvesting system - Product Code ONA
  • Reason
    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.
  • 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

Device

Sterile Disposable Kit
  • Model / Serial
    Model number FP-45547
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.
  • Product Description
    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.
  • Manufacturer
    Restoration Robotics

Manufacturer

Restoration Robotics
  • Manufacturer Address
    Restoration Robotics, 128 Bayview Drive, San Jose CA 95134
  • Manufacturer Parent Company (2017)
    Restoration Robotics, Inc
  • Source
    USFDA