Recall Z-0353-2014— Restoration Robotics
Class II · Terminated
Class II FDA medical device recall by Restoration Robotics, initiated 2013-10-13, terminated 2013-12-10. It names one FDA 510(k) clearance: K123548. 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 follicular extractions.. 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..
- Recalling firm
- Restoration Robotics
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-10-13
- Terminated
- 2013-12-10
- Firm location
- San Jose, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 follicular extractions.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.