FDA Device recall Z-0355-2014
Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067
- FDA Device
- Class II
- terminated
- Published 2013-11-27
On 2013-11-27 the FDA classified a Class II recall of Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067 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-0355-2014 |
| 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
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 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-45547 |
|---|
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-0355-2014%22
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