Nobel Biocare Recalls Guided Surgery Kit Instructions for Incorrect Drill Protocol
Nobel Biocare is recalling 231 Guided Surgery Kits because the Instructions for Use contain an incorrect drill protocol. The kits are used for NobelParallel CC Implants.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard is an incorrect instruction in the documentation (drill protocol) rather than a physical defect in the device itself, and no injuries or illnesses are reported in the source text.
Plain-English summary
Nobel Biocare USA LLC is recalling 231 units of the Nobel Parallel CC Guided Surgery Kit, Article # 38072. The recall involves the Instructions for Use (IFU) titled "NobelGuide for NobelParallel Conical Connection" (id # 2002) and the Manual titled "Guided Surgery with NobelParallel Conical Connection" (id # 79423). The Guided Surgery Kit is used as part of the installation process of NobelParallel CC Implants.
The recall was initiated because the Instructions for Use contain an incorrect drill protocol. The purpose of the IFU is to instruct the user how to use the products safely, and the purpose of the manual is to guide the user through the usage of NobelGuide for NobelParallel CC.
The affected products were distributed worldwide, including the United States (nationwide) and Austria, Belgium, Canada, Germany, Denmark, Spain, France, Great Britain, Italy, Netherlands, Norway, Poland, Portugal, Russia, and Turkey. All lots of Article 38072 are affected.
The recalled product
- Product
- 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…
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implants
- Affected units
- 231
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Article 38072-all lots
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · Nobel Biocare Usa Llc
See all →- HighNobelReplace dental implant components recalled for driver engagement defect
FDA (Devices) · 2022-03-02
- SevereNobel Biocare Recalls Dental Implants Due to Incorrect Length Labeling
FDA (Devices) · 2020-06-10
- ModerateNobel Biocare Recalls Dental Implant Healing Abutments Due to Sizing Error
FDA (Devices) · 2020-06-10
- ModerateNobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screws
FDA (Devices) · 2020-05-13
- ModerateNobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screw Risk
FDA (Devices) · 2020-05-13
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- ModerateNobel Biocare Dental Implant Recall Due to Incorrect Length Labeling
FDA (Devices) · 2020-05-13
- ModerateNobel Biocare Recalls Guided Start Drills Due to Sterility Concerns
FDA (Devices) · 2020-02-26
- ModerateNobel Biocare Recalls Zirconia Abutment Retrieval Instruments Due to Dimensional Error
FDA (Devices) · 2015-07-22
- ModerateNobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screw Risk
FDA (Devices) · 2020-05-13
- HighNobel Biocare Guided Tapered Drills Recalled for Sterility Concerns
FDA (Devices) · 2020-02-26
- LowDannoritzer Laparoscopy Instruments IFU Recalled for Unvalidated Cleaning Instructions
FDA (Devices) · 2018-10-10