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Rhoton Spetzler Type Set

KOROS U.S.A., INC. · Model 7793-00 · UDI-DI 10840199544223

GDI LXC Prescription

510(k) clearances

307

Adverse events (5 deaths)

Recalls

273

Facilities

Description

Rhoton Spetzler Type Titanium Set Consists of the Following: 1 x 7793-01, 1 x 7793-02, 1 x 7793-03, 1 x 7793-04, 1 x 7793-05, 1 x 7793-06, 1 x 7793-07, 1 x 7793-08, 1 x 7793-09, 1 x 7793-10, 1 x 7793-11, 1 x 7793-12, 1 x 7793-13, 1 x 7793-15, 1 x 7793-15, 1 x 7793-16, 1 x 7793-17, 1 x 7793-18, 1 x 7793-19, 1 x 7793-20, 1 x 7793-21, 1 x 7793-22 & 1 x 7793-23

Recalls

Date	Firm	Reason
2015-02-11	EXP Pharmaceutical Services Corp	EXP did not register as a medical device establishment, list the devices being recalled, or establish its own quality system and instead relied on the fact that its vendors were re
2011-12-09	Progressive Medical Inc	Some of the sterile packages had broken seals.
2011-10-28	Progressive Medical Inc	The tip of the product could come loose or unravel.
2010-03-01	He, Inc	Sterile product packaging contains weak seals, which may result in compromised product sterility.
2008-08-08	Sterilmed Inc	SteriMed, Inc is conducting a product removal of a small group of devices individually packaged and sealed within a pouch. The removal is being conducted because the possibility e
2007-11-06	Ethicon Endo-Surgery Inc	Sterility (package integrity) compromised; Damaged packaging may have compromised the sterility of the devices.

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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.