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Clearview Black Belt Retractor Starter Set

KOROS U.S.A., INC. · Model 7319-98T · UDI-DI 10840199501721

GZT Prescription

510(k) clearances

112

Adverse events

Recalls

Facilities

Description

Clearview Black Belt Retractor Starter Set Consists of the Following: Black Finish Stainless Steel Retractor Frames and Blue Finish Titanium Blades. 1x 7320-22T - Retractor frame Right 1x 7320-30T - Retractor frame Offset 2x 7320-40T - Blade Inserting Angled Clamps 2x 7322-34T - Pronged Blade Ti 34 mm, 2x 7322-40T - Pronged Blade Ti 40 mm, 2x 7322-45T - Pronged Blade Ti 45 mm, 2x 7322-50T - Pronged Blade Ti 50 mm, 2x 7322-55T - Pronged Blade Ti 55 mm, 2x 7322-60T - Pronged Blade Ti 60 mm, 2x 7324-34T - Blunt Blade Ti 34 mm, 2x 7324-40T - Blunt Blade Ti 40 mm, 2x 7324-45T - Blunt Blade Ti 45 mm, 2x 7324-50T - Blunt Blade Ti 50 mm, 2x 7324-55T - Blunt Blade Ti 55 mm, 2x 7324-60T - Blunt Blade Ti 60 mm, 1x 7319-90T - Sterilizing Instrument Case, 1.5 x 11 x 13"

Recalls

Date	Firm	Reason
2018-06-19	Nico Corp.	Mislabeled hook pouch included a transport/storage label rather than the product label containing key product information such as part number, lot number, and expiration date, etc
2012-08-21	Vycor Medical, Inc.	Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.
2012-07-17	Nico Corp.	BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packag
2012-07-17	Nico Corp.	BrainPath sheaths were mislabeled. Sheaths which measure 50mm were labeled as 60mm. The length callout on the label does not match the actual length of the sheath within the packag
2007-12-19	Abbott Spine	Dislodged Collar Spring; The collar spring binding on the shaft of generic handle used with multiple surgical instruments has the potential to release the device's internal bearing
2003-02-26	Ohio Medical Instrument Co Inc	The component was manufactured with an insufficient weld that could break during use.

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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.