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Tilting Arm Black Belt Retractor Starter Set

KOROS U.S.A., INC. · Model 7319-98TA · UDI-DI 10840199501738

GZT Prescription

510(k) clearances

112

Adverse events

Recalls

Facilities

Description

Tilting Arm Clearview Black Belt Retractor Starter Set Consisting of the Following: Stainless Steel Retractor Frames and Blue Finish Titanium Blades. 1x 7320-22TA - Tilting Arm Retractor Frame Right, 1x 7320-30TA - Tilting Arm Retractor Frame Offset, 2x 7320-40T - Black Belt Retractor Blade Inserting Clamp SST, 2x 7322-34T - Black Belt Blade Pronged Ti 34mm, 2x 7322-40T - Black Belt Blade Pronged Ti 40mm, 2x 7322-45T - Black Belt Blade Pronged Ti 45mm, 2x 7322-50T - Black Belt Blade Pronged Ti 50mm, 2x 7322-55T - Black Belt Blade Pronged Ti 55mm, 2x 7322-60T - Black Belt Blade Pronged Ti 60mm, 2x 7324-34T - Black Belt Blade Blunt Ti 34mm, 2x 7324-40T - Black Belt Blade Blunt Ti 40mm, 2x 7324-45T - Black Belt Blade Blunt Ti 45mm, 2x 7324-50T - Black Belt Blade Blunt Ti 50mm, 2x 7324-55T - Black Belt Blade Blunt Ti 55mm, 2x 7324-60T - Black Belt Blade Blunt Ti 60mm, 1x 7319-90 - Instrument Sterilizing Case 13x11x1.5"

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.