Nobel Biocare Dental Implants Recalled for Packaging Material Contamination
Nobel Biocare is recalling 32 units of Replace Select Tapered TiU RP dental implants because packaging material may leave a sticky substance on the implant surfaces.
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, but the source text describes a packaging defect (sticky substance) without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Nobel Biocare USA LLC is recalling 32 units of Replace Select Tapered TiU RP 4.3x11.5mm dental implants, Article No. 36107. The affected units are from Batch No. 13011452 and 13011453. The recall is due to a material in the packaging that 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 consumers should stop using the affected implants and contact Nobel Biocare USA LLC for further instructions or a replacement.
The recalled product
- Product
- Replace Select Tapered TiU RP 4.3x11.5mm, Article No. 36107.
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implants
- Hazard
- Affected units
- 32
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 (2)
- Batch No. 13011452
- 13011453.
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.
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