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Medicon eG. Chirurgiemechaniker-Genossenschaft · Model 57.58.63 · UDI-DI 04046826424725

GZT Prescription
10
510(k) clearances
111
Adverse events
6
Recalls
80
Facilities

Description

Cervicalino PEEK retr set w PEEK blades

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.