Restoration Robotics Recall: Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Tu
Restoration Robotics Recall: Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Tu is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Restoration Robotics; Product: Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin
| Recalling firm | Restoration Robotics |
|---|---|
| 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. |
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Terminated |
| Distribution | Worldwide Distribution - USA Nationwide in the countries of: Korea, Japan, Singapore, Thailand, United Kingdom, Canada, and Taiwan. |
| Recall initiated | 20131013 |
| Recall number | Z-0353-2014 |
| Category | device |
| State | CA |
| Country | United States |
$29/mo
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