Nobel Biocare Recalls Dental Implant Healing Abutments Due to Sizing Error
Nobel Biocare is recalling specific dental implant healing abutments because they were packaged with the wrong size device.
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, and the hazard involves a packaging error (wrong size device) without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Nobel Biocare USA LLC is recalling 16 units of the Healing Abutment Conical Connection RP 0 3.6 x 5mm (REF: 36644, UDI: 07332747034462). The recall was initiated because packaged dental implant healing abutments were found to contain the wrong size device.
The affected product is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue in the upper or lower jaw. A total of 234 pieces were distributed globally, with 16 units sent to the United States. The US distribution was nationwide, including the states of Tennessee, Illinois, Michigan, and New York. The product was also distributed in Austria, Russia, Belgium, Germany, the United Kingdom, Norway, Poland, and Portugal.
The specific lot number for the recalled product is 13076845. Consumers and healthcare providers should stop using the affected devices and contact the manufacturer for further instructions.
The recalled product
- Product
- Healing Abutment Conical Connection RP 0 3.6 x 5mm, REF: 36644, UDI: 07332747034462 - Product Usage: Dental implant abutments are intended to be used in the upper or lower jaw and used for supporting tooth replacements to restore chewing function. The Healing Abutment is…
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implant
- Hazard
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 13076845
Distribution
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