Product Wiki · Recalls · U.S. FDA — Device Enforcement

Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit… — recall Z-2375-2016

U.S. FDA — Device Enforcement · United States · 2016-07-20 · Class II

As described by U.S. FDA — Device Enforcement: Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for NobelParallel Conical Connection", id # 2002 and Manual: Guided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided Surgery Kit. The

Compiled from an official source — the facts on this page are reproduced from the issuing authority’s own published notice, which is linked above. No AI-generated text appears on this page. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2375-2016
Date of alert
2016-07-20
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Nobel Biocare Usa Llc
Product category
device
Product type
Devices
Recall status
Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution: US (nationwide) and Countries of: Austria, Belgium, Canada, Germany, Denmark, Spain, France, Great Britain, Italy, Netherlands, Norway, Poland, Portugal, Russia, and Turkey.
Reported risk: Incorrect drill protocol in the Instructions for Use (IFU)
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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