Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Instructions for Use (IFU) and Manual NobPrl CC Guided Surgery Recalled by Nobel Biocare Usa Llc Due to Incorrect drill protocol in the Instructions for Use...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Nobel Biocare Usa Llc directly.
Affected Products
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 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.
Quantity: 231 kits
Why Was This Recalled?
Incorrect drill protocol in the Instructions for Use (IFU)
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Nobel Biocare Usa Llc
Nobel Biocare Usa Llc has 66 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report