Z-0353-2014 Class II Terminated
FDA device recall Z-0353-2014 was initiated by Restoration Robotics on October 13, 2013 and is designated Class II. 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 pro… The recall status is terminated (terminated December 10, 2013). Affected quantity: 515 in US. 315 International.(included all packaging configurations).
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2013
- Initiation Date
- October 13, 2013
- Termination Date
- December 10, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 515 in US. 315 International.(included all packaging configurations)
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.
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.
Distribution Pattern
Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan.
Code Information
Model number FP-45384