FDA Device

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.

Hazard

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.

What You Should Do

Remedy

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

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Products

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 res
Brand
Restoration Robotics
UPC
Model number FP-45384

Units Affected

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

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