Restoration Robotics: Medical Device Recall in 2013 - (Recall #: Z-0353-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: October 13, 2013

Date Posted: November 27, 2013

Recall Number: Z-0353-2014

Event ID: 66558

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.

Status: Terminated

Product Quantity: 515 in US. 315 International.(included all packaging configurations)

Code Information:

Model number FP-45384

Distribution Pattern:

Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.

Voluntary or Mandated:

Voluntary: Firm initiated