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Black Belt Cervical Retractor Basic Set

KOROS U.S.A., INC. · Model 7320-00 · UDI-DI 10840199501769

GZT Prescription

510(k) clearances

111

Adverse events

Recalls

Facilities

Description

Black Belt Cervical Retractor Basic Set, Consists of the Following: Black Finish Stainless Steel Frames and Blades. 1x 7320-22 - Korpectomy Retractor frame Right 1x 7320-20 - Retractor frame Left 1x 7320-30 - Retractor frame Offset 2x 7320-40 - Blade Inserting Clamps 2x 7322-34 - Pronged Blade 34mm, 2x 7322-40 - Pronged Blade 40mm, 2x 7322-45 - Pronged Blade 45mm, 2x 7322-50 - Pronged Blade 50mm, 2x 7322-55 - Pronged Blade 55mm, 2x 7322-60 - Pronged Blade 60mm, 2x 7322-70 - Pronged Blade 70mm, 2x 7324-34 - Blunt Blade 34mm, 2x 7324-40 - Blunt Blade 40mm, 2x 7324-45 - Blunt Blade 45mm, 2x 7324-50 - Blunt Blade 50mm, 2x 7324-55 - Blunt Blade 55mm, 2x 7324-60 - Blunt Blade 60mm, 2x 7324-70 - Blunt Blade 70mm, 4x 7326-40 - Two-Level Blade Pronged 40mm, 4x 7326-47 - Two-Level Blade Pronged 47mm, 4x 7326-55 - Two-Level Blade Pronged 55mm, 2x 7328-40 - Two-Level Blade Blunt 40mm, 2x 7328-47 - Two-Level Blade Blunt 47mm, 2x 7328-55 - Two-Level Blade Blunt 55mm, 1x 7320-90 - Sterilizing Instrument Case with silicone pads

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.