Z-0353-2014Class II

Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma

Name: Z-0353-2014 Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma
Creator: Restoration Robotics
Published: 2013-10-13
License: https://open.fda.gov/license/

Venus Concept Inc. / initiated 2013-10-13 / Terminated / root cause: manufacturing process

FDA source

Restoration Robotics began a recall of Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin Tensioner is applied to patients scalp... on 2013-10-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0353-2014
Classification: Class II
Status: Terminated
Initiated: 2013-10-13
Posted: 2013-11-18
Terminated: 2013-12-10
Recalling firm: Venus Concept Inc.
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.
Product code: ONA Computer Assisted Hair Harvesting System
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Restoration Robotics sent an Urgent Recall letters dated October 13, 2013 to all distributors via first class mail. Direct accounts were notified by phone as well as fax. Customers were informed of the affected product, problem and actions to be taken. Replacement products are being distributed to each site and will be delivered to each customer. For questions call 408-883-6760
Quantity in commerce: 515 in US. 315 International.(included all packaging configurations)
Distribution: Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.
Product codes and lots: Model number FP-45384

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0353-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0353-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-18
Z-0354-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-18
Z-0355-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-18
Z-0356-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-18

Product code ONA

K123548Class IIThe Artas SystemRestoration Robotics, Inc. / cleared 2013-02-25

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)