Nobel Biocare Dental Implant Recall Due to Incorrect Length Labeling
Nobel Biocare is recalling 228 dental implants because the packaging label incorrectly lists the length as 7mm instead of the actual 10mm.
What this means for you
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, and the hazard is a minor labeling error regarding dimensions without reported injuries or illnesses, fitting the Moderate severity criteria.
Plain-English summary
Nobel Biocare USA LLC is recalling 228 units of the NobelParallel Conical Connection NP endosseous dental implant (REF 37965, Lot 12129104). The recall was initiated because the top label on the immediate packaging may incorrectly indicate an implant length of 7mm, which is shorter than the actual implant length of 10mm.
The affected products were distributed internationally to Russia only. These implants are intended to be used in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore chewing function.
Consumers and healthcare providers should stop using the affected implants and contact Nobel Biocare USA LLC for further instructions or a replacement.
The recalled product
- Product
- NobelParallel Conical Connection NP, 3.75x10mm (Endosseous Dental Implant); REF 37965; UDI (01)07332747091441(10)12129104(17)240203 - Product Usage: are intended to be used in the upper or lower jaw bone (osseointegration) and used for anchoring or supporting tooth replacements
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implant
- Hazard
- Affected units
- 228
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)
- Lot:12129104
Distribution
Distribution scope not specified by the agency.
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 →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02