Reported Aug 17, 2016 · Terminated
Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Kit Instructions for Use (IFU): "NobelGuide for…
Nobel Biocare USA LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nobel Biocare Usa Llc · 22715/22725 Savi Ranch Pkwy · Yorba Linda, CA · 92887
Is this the product you have?
- Instructions for Use (IFU) and Manual NobPrl CC Guided
- Surgery Kit Instructions for Use (IFU)"NobelGuide for NobelParallel Conical Connection", id # 2002
- and ManualGuided Surgery with NobelParallel Conical Connection", id # 79423. Article # 38072, Nobel Parallel CC Guided Surgery Kit. The Guided Surgery Kit is used as part of the installation process of NobelParallel CC Implants. The purpose of the IFU is to instruct the user how to use the products safely. The purpose of the manual is to guide the user through the usage of NobelGuide for NobelParallel CC
- Lot codes and dates
- Article 38072-all lots
- Amount recalled
- 231 kits
Where it was sold
- Nationwide
Why it was recalled
Incorrect drill protocol in the Instructions for Use (IFU)
This product could cause temporary or reversible health problems — stop using it.
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