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Disposable Site Making & Implantation Kit, Sterile and Non Sterile, iX

RESTORATION ROBOTICS, INC. · Model 19G · UDI-DI 00850470007630

ONA Prescription
1
510(k) clearances
2
Adverse events
4
Recalls
2
Facilities

Recalls

DateFirmReason
2013-10-13Restoration RoboticsReports 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 dur
2013-10-13Restoration RoboticsReports 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 dur
2013-10-13Restoration RoboticsReports 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 dur
2013-10-13Restoration RoboticsReports 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 du

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.