Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination
Nobel Biocare is recalling 38 units of NobelReplace CC PMC RP 5.0x13mm dental implants because packaging material may leave a sticky substance on the implant surfaces.
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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a potential contamination from packaging material, which fits the criteria for a moderate severity recall involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Nobel Biocare USA LLC is recalling 38 units of NobelReplace CC PMC RP 5.0x13mm dental implants (Article No. 37298, Batch No. 13010296). The recall was initiated because a material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and, in some cases, on the first threads.
The affected products were distributed nationwide in the United States and internationally to Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, United Kingdom, Greece, Croatia, Hungary, Ireland, Italy, Lithuania, Luxembourg, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Sweden, Turkey, and United Arab Emirates.
Healthcare professionals and patients who have received or are considering these specific dental implants should contact Nobel Biocare USA LLC for further instructions on how to proceed. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- NobelReplace CC PMC RP 5.0x13mm, Article No. 37298.
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implants
- Affected units
- 38
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)
- Batch No. 13010296
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 27 recalled by Nobel Biocare Usa Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 27 products in this recall →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 Dental Implant Recall Due to Incorrect Length Labeling
FDA (Devices) · 2020-05-13
- ModerateNobel Biocare Recalls Dental Implant Abutments Due to Incorrect Screw Risk
FDA (Devices) · 2020-05-13
Same hazard · contamination
See all →- SevereFDA Recalls Tirzepatide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAvid Medical Recalls Robotic Prostatectomy Packs for Lubricant Contamination
FDA (Devices) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- ModerateAVID Medical Recalls GYN Laparoscopy Kits for Potential Lubricant Contamination
FDA (Devices) · 2026-10-14
- ModerateAvid Medical Recalls Davinci Trucustom Bundles Due to Lubricant Contamination
FDA (Devices) · 2026-10-14
Similar recalls
- HighNobelReplace Dental Implant Recall Due to Incorrect Measurement Labeling
FDA (Devices) · 2020-08-26
- 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 Screw Risk
FDA (Devices) · 2020-05-13
- HighDental implants recalled for manufacturing defect affecting sterile packaging
FDA (Devices) · 2025-02-12
- SevereNobel Biocare Recalls Dental Implants Due to Incorrect Length Labeling
FDA (Devices) · 2020-06-10
- ModerateNobel Biocare Recalls Dental Abutments Due to Incorrect Screw Risk
FDA (Devices) · 2020-05-13