Home / Recalls / Restoration Robotics / Z-0355-2014

Z-0355-2014 Class II Terminated

Recalled by Restoration Robotics — San Jose, CA

Recall Details

Product Type
Devices
Report Date
November 27, 2013
Initiation Date
October 13, 2013
Termination Date
December 10, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
515 US, 315 International (all packaging cnfigurations)

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.

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.

Distribution Pattern

Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.

Code Information

Model number FP-45547

Other recalls by Restoration Robotics

  • Z-0353-2014 Class II — Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterili (October 13, 2013)
  • Z-0354-2014 Class II — ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuu (October 13, 2013)
  • Z-0356-2014 Class II — ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner (October 13, 2013)