Device product
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.
Z-0356-2014
Product summary
- Event
- Event 66558
- Status
- Terminated
- Classification
- Class II
- Quantity
- 515 US, 315 International (all Packaging configurations.
- Official record key
device-enforcement:Z-0356-2014
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-45399
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.