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Black Belt Cervical Retractor Extended Set

KOROS U.S.A., INC. · Model 7320-05 · UDI-DI 10840199501820

GZT Prescription
1
510(k) clearances
112
Adverse events
6
Recalls
81
Facilities

Description

Black Belt Cervical Retractor Extended Set Consists of the Following: 1x 7320-22 - Korpectomy Retractor frame Right, 1x 7320-20 - Retractor Frame Left, 1x 7320-30 - Retractor Frame Offset, 2x 7320-40 - Blade Inserting Clamp, 1x 7321-10 - Micro Discectomy Adaptor, 1x 7321-20 - Spike Blade 70mm, 1x 7321-30 - T-Shape Blade 70mm, 1x 7321-40 - Inner Spine Ligament Blade 70mm, 2x 7322-34 - Black Belt Blade Pronged 34mm, 2x 7322-40 - Black Belt Blade Pronged 40mm, 2x 7322-45 - Black Belt Blade Pronged 45mm, 2x 7322-50 - Black Belt Blade Pronged 50mm, 2x 7322-55 - Black Belt Blade Pronged 55mm, 2x 7322-60 - Black Belt Blade Pronged 60mm, 2x 7322-70 - Black Belt Blade Pronged 70mm, 2x 7324-34 - Black Belt Blade Blunt 34mm, 2x 7324-40 - Black Belt Blade Blunt 40mm, 2x 7324-45 - Black Belt Blade Blunt 45mm, 2x 7324-50 - Black Belt Blade Blunt 50mm, 2x 7324-55 - Black Belt Blade Blunt 55mm, 2x 7324-60 - Black Belt Blade Blunt 60mm, 2x 7324-70 - Black Belt Blade Blunt 70mm, 4x 7326-40 - BB Two-Level Blade Pronged 40mm, 4x 7326-47 - BB Two-Level Blade Pronged 47mm, 4x 7326-55 - BB Two-Level Blade Pronged 55mm, 2x 7328-40 - BB Two-Level Blade Blunt 40mm, 2x 7328-47 - BB Two-Level Blade Blunt 47mm, 2x 7328-55 - BB Two-Level Blade Blunt 55mm, 1x 7322-85 - Black Belt Blade Pronged 85mm, 1x 7322-75 - Extra Long Retractor Rack 15cm, 1x 7320-90 - Sterilizing Instrument Case with Silicone Pads

Recalls

DateFirmReason
2018-06-19Nico 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
2012-08-21Vycor Medical, Inc.Vycor Medical recalled their VBAS (Vycor Viewsite Brain Access System) because an unidentified black fiber was found on the device.
2012-07-17Nico 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
2012-07-17Nico 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
2007-12-19Abbott SpineDislodged 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
2003-02-26Ohio Medical Instrument Co IncThe 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.