Reported Nov 27, 2013 · Terminated
ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385;…
Restoration Robotics
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Restoration Robotics · 128 Bayview Drive · San Jose, CA · 95134
Is this the product you have?
6 of 6 products
| # | Product as published |
|---|---|
| 1 | ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384 |
| 2 | Inner Needle with Vacuum Tube FP-45385 |
| 3 | dissection Punch 4.0mm FP 23304 |
| 4 | Saline Nose Cone FP-45387 |
| 5 | Follicle Trap FP 23306 |
| 6 | 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. |
- Lot codes and dates
- Model number FP-45399
- Amount recalled
- 515 US, 315 International (all Packaging configurations.
This recall covers 4 products
The agency filed one notice per product. You are reading one of them; the other 3 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Restoration Robotics recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.