Home / Recalls / Restoration Robotics / Z-0356-2014

Z-0356-2014 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 configurations.

Product Description

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.

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-45399