Nobel Biocare Recalls Dental Implants Due to Packaging Material Contamination
Nobel Biocare is recalling 73 dental implants because packaging material may leave a sticky substance on the implant surfaces and threads.
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 material defect (sticky substance) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Nobel Biocare USA LLC is recalling 73 units of Replace Select Tapered TiU WP 5.0x13mm dental implants, Article No. 29424. The affected units are identified by Batch No. 13011341 and 13013046. These root-form endosseous implants are intended to be surgically placed in the jawbone to support prosthetic devices such as artificial teeth.
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. This contamination could potentially affect the integrity or handling of the medical device.
The affected products were distributed worldwide, including nationwide in the United States and internationally to numerous countries such as Austria, Australia, Belgium, Canada, Germany, and the United Kingdom. Healthcare providers and patients who have received these specific implants should contact Nobel Biocare USA LLC for further instructions on how to proceed.
The recalled product
- Product
- Replace Select Tapered TiU WP 5.0x13mm, Article No. 29424. Nobel Biocare's Dental Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in…
- Manufacturer
- Nobel Biocare Usa Llc
- Category
- Medical Device — Dental Implants
- Affected units
- 73
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. 13011341
- 13013046.
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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