Device 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.
Z-0354-2014
Product summary
- Event
- Event 66558
- Status
- Terminated
- Classification
- Class II
- Quantity
- 515 US, 315 International (all packaging configurations)
- Official record key
device-enforcement:Z-0354-2014
Official wording
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.
Code information: Model number FP-45616 and FP45173
Distribution pattern: Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.
Derived failure modes
-
Unknown
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.