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Clear View Black Belt Extended Retractor System

KOROS U.S.A., INC. · Model 7320-05T · UDI-DI 10840199501882

GZT Prescription

510(k) clearances

112

Adverse events

Recalls

Facilities

Description

"Radiolucent ClearView Black Belt Extended Retractor Set Consists of the Following: Set consists of: 1 7320-22T 1 ea Korpectomy Retractor Frame, Right 2 7320-20T 1 ea Retractor Frame, Left 3 7320-30T 1 ea Retractor Frame, Offset 4 7320-40T 2 ea Blade Inserting Clamps 5 7322-34T thru 70T 2 ea Pronged Ti Blades (14 total) 6 7324-34T thru 70T 2 ea Blunt Ti Blades (14 total) 7 7326-40T,-47T,-55T 4 ea Two-Level Ti Blades, Pronged 8 7328-40T,-47T,-55T 2 ea Two-Level Ti Blades, Blunt 9 7320-90T 1 ea Sterilizing Instrument Case with silicone inserts. 10 7321-10M 1 ea Microdiscectomy Adaptor 11 7321-20T 1 ea Spike Blade, 70 mm 12 7321-30T 1 ea T-Shape Blade, 70 mm 13 7321-40T 1 ea Inner Spine Ligament Blade, 70 mm 14 7322-85T 1 ea Pronged Ti Blade, 22x85 mm 15 7322-75T 1 ea 15 cm long Retractor Rack"

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.