FDA Device recall Z-0354-2014
ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384
- FDA Device
- Class II
- terminated
- Published 2013-11-27
On 2013-11-27 the FDA classified a Class II recall of ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384 by Restoration Robotics, citing 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 du….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0354-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-10-13 |
| Published | 2013-11-27 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Restoration Robotics |
| Distribution | US |
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.
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.
Identifiers
| code_info | Model number FP-45616 and FP45173 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0354-2014%22
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