Product Wiki · Recalls · Health Canada — Medical Devices

NOBEL PARALLEL CC GUIDED SURGERY KIT (2016-07-20) — recall 56014

Health Canada — Medical Devices · Canada · 2016-08-10 · Type III

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Agency
Health Canada — Medical Devices
Recall identifier
56014
Date of alert
2016-08-10
Country / jurisdiction
Canada
Risk level
Type III
Risk type
recall
Product category
Medical devices
Product type
Medical devices
Notice status
Archived by the issuing authority — kept for reference
Reported risk: Nobel quality management systems have detected that the instructions for use (IFU) and the manual for guided surgery with NobelParallel Conical Connection implants include an incorrect drill protocol for the fully guided surgery using the 4.3 mm implant diameter in soft bone. The IFU and manual are related to the NobelParallel CC Guided Surgery Kit, article #38072. The instructions printed on the kit plate itself, placed at the top of the plate, reference the correct drills for all implant diameters and bone types.
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/nobel-parallel-cc-guided-surge

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