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Black Belt II Tilting Arm Retractor Basic Set All Titanium

KOROS U.S.A., INC. · Model 7320-00MU · UDI-DI 10840199501783

GZT Prescription

510(k) clearances

112

Adverse events

Recalls

Facilities

Description

Black Belt II Tilting Arm Retractor Basic Set All Titanium, Consists of the Following: 1x 7320-10TU - Black Belt II Ti Tilting Arm Retractor Frame Right, 1x 7320-20TU - Black Belt II Ti Tilting Arm Retractor Frame Left, 1x 7320-30TU - Black Belt II Ti Tilting Arm Retractor Frame Offset, 2x 7320-40M - Black Belt Retractor Blade Inserting Clamp SST, 2x 7322-34M - Black Belt Ti Blade Pronged 34mm, 2x 7322-40M - Black Belt Ti Blade Pronged 40mm, 2x 7322-45M - Black Belt Ti Blade Pronged 45mm, 2x 7322-50M - Black Belt Ti Blade Pronged 50mm, 2x 7322-55M - Black Belt Ti Blade Pronged 55mm, 2x 7322-60M - Black Belt Ti Blade Pronged 60mm, 2x 7322-70M - Black Belt Ti Blade Pronged 70mm, 2x 7324-34M - Black Belt Ti Blade Blunt 34mm, 2x 7324-40M - Black Belt Ti Blade Blunt 40mm, 2x 7324-45M - Black Belt Ti Blade Blunt 45mm, 2x 7324-50M - Black Belt Ti Blade Blunt 50mm, 2x 7324-55M - Black Belt Ti Blade Blunt 55mm, 2x 7324-60M - Black Belt Ti Blade Blunt 60mm, 2x 7324-70M - Black Belt Ti Blade Blunt 70mm, 2x 7326-40M - BB Two-Level Ti Blade Pronged 40mm, 2x 7326-47M - BB Two-Level Ti Blade Pronged 47mm, 2x 7326-55M - BB Two-Level Ti Blade Pronged 55mm, 2x 7328-40M - BB Two-Level Ti Blade Blunt 40mm, 2x 7328-47M - BB Two-Level Ti Blade Blunt 47mm, 2x 7328-55M - BB Two-Level Ti Blade Blunt 55mm, 1x 7320-90M - Black Belt Retractor Instrument Case

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.