FDAFDA · Food and drugs·Recall number Z-0354-2014
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.
Published November 27, 2013 · Recall initiated: October 13, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Restoration Robotics
- Distributor
- Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.
- Lot
- Model number FP-45616 and FP45173
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.