Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0354-2014 — ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; Dissection Punch 4.0mm FP-23304; Saline Nose Cone FP-45387; Follicle Trap - FP-23306 and Non-sterile Disposable Clinical Kit FP -23267): and ARTAS Disposable Kits, 18 Gauge Epsilon (Contains Disposabl

U.S. FDA — Device Enforcement · United States · 2013-10-13 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0354-2014
Date of alert: 2013-10-13
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Restoration Robotics
Product category: device
Product type: Devices

Reported risk: 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.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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