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Restoration Robotics recalls ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; Dissection Punch 4.0mm
Recalled November 27, 2013 · FDA recall Z-0354-2014 · Restoration Robotics
Hazard
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 Class II
Units
515 US, 315 International (all packaging configurations)
Sold at
Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.
Description
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.
Product
ARTAS Disposable 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 and Non-sterile Disposable Clinical Kit FP -23267): and ARTAS Disposable Kits, 18 Gauge Epsilon (Contains Disposable Kit, 18 Gauge Epsilon FP 45547 and Non-Sterile Disposable Kit FP-23267). 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.
Manufacturer(s)
Restoration Robotics
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →