The Recall Desk

FDA (Devices) recall action 66558

Restoration Robotics recalled 4 products on 2013-11-27

The FDA (Devices) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.

Products
4
Announced
2013-11-27
Critical
0
Units
—

Why these products were recalled

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.

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.

The agency’s own wording, quoted from the enforcement report.

1–4 of 4

  • ModerateFDA (Devices)··2013-11-27

    Restoration Robotics Recalls ARTAS Disposable Kits Due to Pin Discoloration

    Restoration Robotics is recalling ARTAS Disposable Kits because skin tensioner pins have discoloration from insufficient cleaning during manufacturing.

    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
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-11-27

    Restoration Robotics Recalls Sterile Disposable Kits Due to Pin Discoloration

    Restoration Robotics is recalling sterile disposable kits used in hair restoration because skin tensioner pins have discoloration from insufficient cleaning.

    Product
    Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-25117, follicle Trap PRT 23999): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting dur
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-11-27

    Restoration Robotics Recalls Epsilon Skin Tensioner Due to Pin Discoloration

    Restoration Robotics is recalling Epsilon Skin Tensioner devices because stainless steel pins may have discoloration from insufficient cleaning during passivation.

    Product
    Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicul
    Category
    Distribution
    0 states
  • ModerateFDA (Devices)··2013-11-27

    Restoration Robotics Recalls ARTAS Hair Restoration Kits Due to Pin Residue

    Restoration Robotics is recalling ARTAS hair restoration kits because skin tensioner pins contain iron and chlorine residue from insufficient cleaning.

    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):
    Category
    Distribution
    0 states